STATLOCK PICC PLUS CRESCENT SLIDING POST

Additional Manufacturer Narrative

THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT THAT THE RETAINER WAS SEPARATING FROM THE SUBSTRATE WAS CONFIRMED AS MANUFACTURING RELATED. TWO STATLOCK STABILIZATION DEVICES WERE RETURNED FOR INVESTIGATION. ONE STATLOCK STABILIZATION DEVICE APPEARED TO BE USED AND ONE WAS RECEIVED IN A SEALED KIT. THE SUBSTRATE OF THE USED SAMPLE HAD SEPARATED FROM THE RETAINER APPROXIMATELY 1CM ALONG THE BOTTOM EDGE OF THE RETAINER AND 0.5CM ALONG THE TOP EDGE OF THE RETAINER. A MICROSCOPIC EXAMINATION REVEALED VARIABLE ADHESIVE THAT REMAINED ATTACHED TO THE UNDERSIDE OF THE RETAINER. THE UNUSED SAMPLE WAS REMOVED FROM THE POUCH AND THE SUBSTRATE WAS REMOVED FROM THE RETAINER. VARIABLE ADHESIVE COVERAGE WAS OBSERVED ON THE BOTTOM OF THE RETAINER. BD IS WORKING CLOSELY WITH MANUFACTURING TO PREVENT RECURRENCE OF THE REPORTED EVENT. A LOT HISTORY REVIEW (LHR) OF JUEW3276 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUEW3276) HAVE BEEN REPORTED FROM THE SAME FACILITY.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PICC DRESSING CHANGE, THE TEGADERM WAS REMOVED AND THE RN NOTICED THAT THE PLASTIC PIECE OF STATLOCK WAS NO LONGER ATTACHED TO THE BUTTERFLY/PATIENT. IT WAS FURTHER REPORTED THAT THE DEVICE HAD BEEN IN USE FOR 7 DAYS. TWO DEVICES WERE RETURNED FOR EVALUATION, ONE USED AND ONE LOT SAMPLE. THIS REPORT ADDRESSES THE SECOND DEVICE, THE LOT SAMPLE.