STATLOCK PICC PLUS SLIDING POST, 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), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A STUCK BLUE POST IS CONFIRMED AND WAS DETERMINED TO BE MANUFACTURING RELATED. ONE PICC PLUS STATLOCK DEVICE WITH A FOAM PAD AND ADJUSTABLE POSTS WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED THE STATLOCK DEVICE WAS RETURNED WITHOUT A LINER. THE RIGHT SIDE OF THE RETAINER WAS OBSERVED TO BE DETACHED FROM THE FOAM PAD AND POOR ADHESIVE COVERAGE WAS OBSERVED ON THE UNDERSIDE OF THE RETAINER OF THE DETACHED PORTION. THE RIGHT BLUE SLIDING POST WAS OBSERVED TO BE OUTSIDE OF AND WEDGED UNDERNEATH ITS TRACK. A MICROSCOPIC OBSERVATION REVEALED THE RIGHT RETAINING BUMPS WERE UNDAMAGED, WHICH INDICATES THE SLIDING POST WAS LIKELY MISASSEMBLED. THE INVESTIGATION WAS FORWARDED TO THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. AWARENESS TRAINING WAS PERFORMED WITH THE MANUFACTURING OPERATORS REGARDING THIS COMPLAINT, AND BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

Description of Event or Problem

IT WAS REPORTED THAT FIX BLUE STICK ON THE STATLOCK. A NEW DEVICE WAS USED. 1/11/2021- DETACHMENT OF THE RETAINER WAS NOTED ON THE RETURNED DEVICE.