DRAINAGE BAG CONNECTOR CONNECTING TUBE

Additional Manufacturer Narrative

INVESTIGATION ¿ EVALUATION. G4 - PMA/510(K) #: EXEMPT. H3 - DEVICE EVALUATED BY MFG? DEVICE NOT RETURNED TO MANUFACTURER. IT WAS REPORTED THAT THE END OF THE DRAINAGE BAG CONNECTOR CONNECTING TUBE WAS CRUSHED DURING AN UNKNOWN PROCEDURE. WHEN THE CUSTOMER USED THE DEVICE, BLOOD WAS NOTED TO BE "SQUIRTING OUT OF THE TUBE". A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. REVIEWS OF DOCUMENTATION INCLUDING QUALITY CONTROL PROCEDURES FOR THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE COMPLETED DUE TO A LACK OF LOT INFORMATION. A SALES REPORT WAS PERFORMED TO DETERMINE A LOT NUMBER; HOWEVER, COOK WAS UNABLE TO NARROW DOWN A LOT NUMBER. BASED ON THE DMR AND LIMITED INFORMATION, COOK WAS NOT ABLE TO FIND EVIDENCE SUGGESTING THE PRODUCT WAS MANUFACTURED OUT OF SPECIFICATION. COOK WAS NOT ABLE TO FIND EVIDENCE OF NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. COOK WAS UNABLE TO REVIEW PRODUCT LABELING AS THIS PRODUCT IS NOT SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET. BASED ON THE INFORMATION PROVIDED, NO RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE DAMAGE WAS MOST LIKELY CAUSED BY TRANSPORT OF THE PRODUCT. THE CUSTOMER STATED THAT THE DEVICE WAS CRUSHED AT THE END POINT OF THE TUBING AND CHOSE TO STILL USE THE DEVICE. THE LIKELY CAUSE OF THE NOTED BLOOD SQUIRTING FROM THE TUBING IS DUE TO THE DEVICE BEING DAMAGED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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

IT WAS REPORTED THAT THE END OF THE DRAINAGE BAG CONNECTOR CONNECTING TUBE WAS NOTED TO BE CRUSHED DURING AN UNKNOWN PROCEDURE. WHEN THE CUSTOMER USED THE DEVICE, BLOOD WAS NOTED TO BE "SQUIRTING OUT OF THE TUBE". A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.