STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP

Additional Manufacturer Narrative

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. THIRTY-ONE SEALED PICC PLUS STATLOCK KITS, ONE OPEN PICC PLUS STATLOCK KIT, ONE FULLY DETACHED RETAINER FROM A PICC PLUS STATLOCK DEVICE, AND TWO FULLY DETACHED PADS FROM PICC PLUS STATLOCK DEVICES WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED ONE OF THE PADS WAS RETURNED WITHOUT A LINER, AND USE RESIDUE WAS OBSERVED ON BOTH PADS. A MICROSCOPIC OBSERVATION REVEALED POOR ADHESIVE COVERAGE AND WHAT APPEARS TO BE SOME ADHESIVE THAT WAS NOT FULLY CURED ON THE UNDERSIDE OF THE SINGLE FULLY DETACHED RETAINER. EACH OF THE SEALED KITS WERE OPEN AND THE STATLOCK DEVICES WITHIN WERE EXAMINED. AT LEAST ONE CORNER AND/OR SIDE OF THE RETAINER OF TWELVE OF THESE SAMPLES WAS FOUND TO BEGIN TO DETACH FROM THE PAD WITH LITTLE FORCE. SOME STRINGS OF WHAT IS LIKELY UNCURED ADHESIVE WERE OBSERVED BETWEEN THE PAD AND THE RETAINER OF SOME OF THESE SAMPLES. THIS INVESTIGATION HAS BEEN FORWARDED TO THE MANUFACTURING FACILITY FOR FURTHER EVALUATION, AND BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT. A LOT HISTORY REVIEW (LHR) OF JUDY2477 SHOWED 13 OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUDY2477) HAVE BEEN REPORTED FROM THE SAME FACILITY IN THE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT CAME IN WITH A BROKEN FIXATION PLASTER. NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2021- FOURTEEN DEVICES WERE CONFIRMED TO BE DETACHED. THIS REPORT ADDRESSES THE EIGHTH DEVICE.