STATLOCK PICC PLUS SLIDING POST, CRESCENT PAD, INCLUDES SKIN PREP

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUES2208 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUES2208) HAVE BEEN REPORTED FROM THE SAME FACILITY IN (B)(6).

Description of Event or Problem

IT WAS REPORTED THAT THE CLAW OF THE RETAINER WAS FOUND TO BE BROKEN. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THERE WAS NO REPORTED PATIENT CONTACT. THIS REPORT ADDRESSES THE FIRST DEVICE.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND BATCH HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, SAMPLE ANALYSIS AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DAMAGED LATCH WAS CONFIRMED BUT THE CAUSE IS UNKNOWN. FIVE PHOTOGRAPHS WERE RETURNED FOR EVALUATION OF THIS COMPLAINT. ONE OF THE PHOTOS WAS OF THE YELLOW DISCOLORED LIDSTOCK FROM THE KIT PACKAGING. THE OTHER FOUR PHOTOS WERE OF A RIGHT SIDE OF A PICC PLUS STATLOCK WITH A FOAM PAD. THE PHOTOS WERE DIFFERENT ANGLES OF THE DOOR ON THE PLASTIC RETAINER. THE TOP PART OF THE LATCH, THAT CLOSES THE DOOR ON THE RETAINER, WAS MISSING. THE TOP EDGE OF THE LATCH WAS UNEVEN WITH THE RIGHT SIDE OF THE LATCH BEING LONGER THAN THE LEFT SIDE OF THE LATCH. THE LINER WAS STILL ATTACHED TO THE FOAM PAD ON THE SAMPLE, INDICATING THAT THE PRODUCT HAD NOT BEEN USED. IT COULD NOT BE DETERMINED FROM THE RETURNED PHOTOS IF THE LATCH BROKE OR IF IT WAS NOT FULLY FORMED DURING THE MANUFACTURING PROCESS. A REVIEW OF MANUFACTURING DOCUMENTS WAS CONDUCTED WHICH FOUND NO DISCREPANCIES OR ANOMALIES DURING THE MANUFACTURE OF THE SUBJECT LOT, THE LOT MET SPECIFICATION AND THERE WAS NOTHING NOTED THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

Description of Event or Problem

IT WAS REPORTED THAT THE THE CLAW OF THE RETAINER WAS FOUND TO BE BROKEN. IT WAS STATED THIS OCCURRED WITH TWO DEVICES. THERE WAS NO REPORTED PATIENT CONTACT. THIS REPORT ADDRESSES THE FIRST DEVICE.