VENTRICLEAR DRAINAGE CATHETER SET

Additional Manufacturer Narrative

CORRECTION: D9 - DEVICE AVAILABLE FOR EVALUATION, H3 H3 - DEVICE EVALUATED BY MFG? THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER FOR EVALUATION. INVESTIGATION ¿ EVALUATION IT WAS REPORTED THAT A HAIR-LIKE FIBER WAS FOUND WITHIN THE SEALED PACKAGING OF A VENTRICLEAR DRAINAGE CATHETER SET. THE PACKAGING WAS NOT OPENED, AND NO PATIENT CONTACT WAS MADE. NO HARM HAS BEEN REPORTED. REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES, AS WELL AS VISUAL INSPECTION OF A CUSTOMER PROVIDED PHOTO, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A CUSTOMER PROVIDED PHOTO SHOWED A HAIR LIKE FIBER INSIDE THE SEALED PACKAGING ADDITIONALLY, 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 DHR FOR THE REPORTED COMPLAINT DEVICE LOT REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. A COMPLAINT HISTORY SEARCH IDENTIFIED NO OTHER EVENTS REPORTED FOR THE RELATED FAILURE MODE. THE INFORMATION PROVIDED UPON REVIEW OF THE DEVICE FAILURE ANALYSIS INDICATES THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, REVIEW OF THE DMR AND DHR SUGGESTS THAT THERE ARE NO ADDITIONAL NONCONFORMING DEVICES IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED THE PRODUCT LABELING, INCLUDING THE INSTRUCTIONS FOR USE (IFU) TITLED "C_T_VVDCABRM_REV3". THE USER FOLLOWED ALL RELEVANT INSTRUCTIONS IN THE IFU RELATED TO THIS FAILURE. BASED ON THE INFORMATION PROVIDED, INSPECTION OF THE CUSTOMER PROVIDED PHOTO, AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THE CAUSE OF THIS EVENT TO BE A QUALITY CONTROL DEFICIENCY. 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

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

Additional Manufacturer Narrative

H3: DEVICE EVALUATED BY MFG? DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. AWAITING DEVICE RETURN. 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 THAT A HAIR-LIKE FIBER WAS FOUND WITHIN THE SEALED PACKAGING OF A VENTRICLEAR DRAINAGE CATHETER SET. THE PACKAGING WAS NOT OPENED, AND NO PATIENT CONTACT WAS MADE. A PHOTO PROVIDED BY THE CUSTOMER CONFIRMS THE PRESENCE OF A HAIR WITHIN THE PACKAGING. NO HARM HAS BEEN REPORTED.