STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP

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 LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DETACHED RETAINER IS CONFIRMED AND WAS DETERMINED TO BE MANUFACTURING RELATED. ONE PICC PLUS STATLOCK DEVICE WITH A TRICOT PAD AND ADJUSTABLE POSTS WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON THE RETURNED SAMPLE. THE RETAINER OF THE DEVICE WAS OBSERVED TO BE COMPLETELY DETACHED, AND A MICROSCOPIC OBSERVATION REVEALED INSUFFICIENT ADHESIVE COVERAGE ON THE UNDERSIDE OF THE DETACHED RETAINER. THE INVESTIGATION WAS FORWARDED TO THE MANUFACTURING FACILITY FOR FURTHER EVALUATION, AND BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT.

Description of Event or Problem

IT WAS REPORTED THE STATLOCK RETAINER CLIP DETACHED. NO OTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUEU0052 SHOWED THREE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY IN THE (B)(6).

Description of Event or Problem

IT WAS REPORTED THE STATLOCK RETAINER CLIP DETACHED. NO OTHER INFORMATION WAS PROVIDED.