DRAINAGE BAG CONNECTOR CONNECTING TUBE

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

PER ADDITIONAL INFORMATION, NEW VINYL CONNECTING TUBE WAS USED AFTER THE FAILURE WAS DISCOVERED.

Additional Manufacturer Narrative

BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION ON 06JUL2023, (B)(6) CENTRE (CANADA) REPORTED AN INCIDENT INVOLVING A DRAINAGE BAG CONNECTOR CONNECTING TUBE (RPN: CTU14.0-30-ST, LOT: 15120278). THE CUSTOMER STATED THAT ON 01JUL2023, THE END PART OF THE DEVICE WHERE THE LURE LOCK IS LOCATED SEPARATED FROM THE TUBING. THE TUBING WAS FOUND ON THE FLOOR NEAR THE PATIENT, SO THE TUBING NEAR THE PATIENT WAS CLAMPED. THE DEVICE WAS REPLACED WITH A NEW CONNECTING TUBE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) IDENTIFIED PROCESS STEPS TO ENSURE THIS NONCONFORMANCE DOES NOT LEAVE THE HOUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 15120278 FOUND NO RELEVANT NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK WAS UNABLE TO REVIEW PRODUCT LABELING, AS THE PRODUCT IS NOT SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET. FROM INFORMATION GATHERED UPON A REVIEW OF THE DMR, THE DHR, AND NO PRODUCT RETURN, COOK WAS NOT ABLE TO FIND EVIDENCE THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. COOK WAS NOT ABLE TO FIND EVIDENCE OF NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. THE PATIENT WAS BED BOUND, BUT IF THERE WAS ENOUGH MOVEMENT IN THE BED, THIS COULD POSSIBLY LEAD TO THIS EVENT. IT IS POSSIBLE THE LURE LOCK ADAPTER WAS NOT IN THE TUBING PROPERLY; HOWEVER, THIS CANNOT BE CONFIRMED WITH NO PRODUCT RETURN. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

Additional Manufacturer Narrative

E1 - CUSTOMER (ENTITY): POSTAL CODE: (B)(6). E3 - OCCUPATION: RISK MANAGEMENT. G4 - PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

Description of Event or Problem

IT WAS REPORTED THE DRAINAGE BAG CONNECTOR CONNECTING TUBE DISCONNECTED FROM THE CHEST TUBE SYSTEM OF AN UNKNOWN PATIENT. THE CLEAR VINYL CONNECTING TUBE WAS USED TO ATTACH THE ATRIUM TUBING TO THE CHEST TUBE VIA A LUER LOCK FOR AN UNKNOWN PATIENT. THE LURED CONNECTOR WAS ATTACHED; HOWEVER, THE CLEAR TUBING WAS FOUND ON THE FLOOR LEAVING AN OPENING/BREAK IN THE CHEST TUBE SYSTEM. THE TUBING WAS IMMEDIATELY CLAMPED NEAR THE PATIENT. PER CUSTOMER, THE BREAK WAS AT A LOCATION OF A MANUFACTURED SEAM WHERE THE CLEAR TUBING IS ATTACHED TO A LURED CONNECTOR THAT IS THEN ATTACHED TO A STOPCOCK. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

Description of Event or Problem

IN ADDITIONAL INFORMATION RECEIVED ON 31AUG2023, IT WAS REPORTED THAT THE PATIENT WAS BED BOUND.

Additional Manufacturer Narrative

THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.