STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP

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 ANALYSIS, APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF DETACHED RETAINERS IS CONFIRMED AND WAS DETERMINED TO BE MANUFACTURING RELATED. TWO PICC PLUS STATLOCK DEVICES WITH TRICOT PADS AND ADJUSTABLE POSTS WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED USE RESIDUE ON ONE OF THE RETURNED SAMPLES. THE RETAINER OF THIS SAMPLE WAS FOUND TO BE ALMOST COMPLETELY DETACHED FROM ITS PAD. THE BOTTOM LEFT CORNER OF THE RETAINER OF THE OTHER RETURNED SAMPLE WAS ALSO FOUND TO BE DETACHED FROM ITS PAD. THE PADS AND THE UNDERSIDES OF THE RETAINERS OF THE RETURNED SAMPLES WERE OBSERVED TO BE SOMEWHAT TACKY. A MICROSCOPIC OBSERVATION REVEALED SOMEWHAT POOR ADHESIVE COVERAGE ON THE UNDERSIDE OF THE DETACHED RETAINERS. STRINGS OF ADHESIVE WERE OBSERVED BETWEEN THE PAD AND THE RETAINER OF BOTH SAMPLES, SUGGESTING THAT THE ADHESIVE DID NOT CURE CORRECTLY. 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. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

Description of Event or Problem

IT WAS REPORTED AT HEMATOLOGY, THERE WERE 2 STATLOCK BANDAGES WHERE THE HARD PVC PIECE DETACHES FROM THE ADHESIVE. THIS REPORT ADDRESSES THE SECOND DEVICE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUGQ2029 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER ( JUGQ2029) HAVE BEEN REPORTED FROM FACILITY IN BELGIUM.

Description of Event or Problem

IT WAS REPORTED AT HEMATOLOGY, THERE WERE 2 STATLOCK BANDAGES WHERE THE HARD PVC PIECE DETACHES FROM THE ADHESIVE. THIS REPORT ADDRESSES THE SECOND DEVICE.