STATLOCK PICC PLUS CRESCENT SLIDING POST

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUEU2085 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUEU2085) HAVE BEEN REPORTED FROM THE SAME FACILITY.

Description of Event or Problem

IT WAS REPORTED "PICC PLUS STATLOCK CATHETER STABILIZATION DEVICE: PLASTIC WINGS DETACHED FROM ADHESIVE BASE DURING ROUTINE APPLICATION." "PATIENT REQUIRED ADDITIONAL STATLOCK APPLICATION/DRESSING CHANGE"

Description of Event or Problem

IT WAS REPORTED "PICC PLUS STATLOCK CATHETER STABILIZATION DEVICE: PLASTIC WINGS DETACHED FROM ADHESIVE BASE DURING ROUTINE APPLICATION." "PATIENT REQUIRED ADDITIONAL STATLOCK APPLICATION/DRESSING CHANGE."

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 SEALED POUCH CONTAINING A PICC PLUS STATLOCK WITH A TRICOT PAD AND ADJUSTABLE POSTS, ONE SEPARATE DETACHED RETAINER WITH ADJUSTABLE POSTS, AND ONE SEPARATE DETACHED TRICOT PAD WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON THE DETACHED TRICOT PAD. A MICROSCOPIC OBSERVATION REVEALED POOR ADHESIVE COVERAGE ON THE UNDERSIDE OF THE DETACHED RETAINER. THE RETAINER OF THE STATLOCK SAMPLE RETURNED IN A SEALED POUCH WAS FOUND TO BE SECURELY BONDED TO ITS PAD AND DID NOT DETACH EASILY. ONCE THIS RETAINER WAS REMOVED BY ADDITIONAL FORCE, SUFFICIENT ADHESIVE COVERAGE WAS OBSERVED ON THE UNDERSIDE OF THE RETAINER OF THIS LOT SAMPLE. THIS 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. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.