STATLOCK PICC PLUS SLIDING POST CRESCENT PAD W/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 APPEARS TO BE MANUFACTURING RELATED. ONE PICC PLUS STATLOCK DEVICE WITH A FOAM PAD AND ADJUSTABLE POSTS, THE DETACHED RETAINER OF WHAT APPEARS TO BE A PICC PLUS STATLOCK DEVICE WITH A FOAM PAD AND ADJUSTABLE POSTS, AND ONE EMPTY PACKAGE WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED A FEW PIECES OF FOAM ON THE BOTTOM SIDE OF THE UNDERSIDE OF THE DETACHED RETAINER. NO DAMAGE WAS OBSERVED ON THE INTACT STATLOCK DEVICE. AN ATTEMPT WAS MADE TO SEPARATE THE RETAINER OF THE INTACT STATLOCK SAMPLE AND WHILE SOME SMALL TEARS FORMED IN THE FOAM PAD, THE RETAINER WAS FOUND TO BE FIRMLY ATTACHED TO THE FOAM PAD. A MICROSCOPIC OBSERVATION REVEALED POOR ADHESIVE COVERAGE ON THE UNDERSIDE OF THE DETACHED RETAINER, WHICH LIKELY OCCURRED DURING THE MANUFACTURING PROCESS. 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. A LOT HISTORY REVIEW (LHR) OF JUEY1089 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE PLASTIC PART OF STATLOCK ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.(B)(6) 2021: THE RETURNED SAMPLE WAS FOUND TO HAVE A DETACHED RETAINER.