STATLOCK SLIDING POST CRESCENT PAD 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 (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. TWO PICC PLUS STATLOCK KITS WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED ONE OF THE KITS WAS RETURNED OPEN AND ONE KIT WAS RETURNED SEALED. THE RETAINER OF THE STATLOCK DEVICE RETURNED IN THE OPEN KIT WAS FOUND TO BE COMPLETELY DETACHED FROM THE PAD, AND THE UNDERSIDE OF THIS DETACHED RETAINER WAS OBSERVED TO BE TACKY. A MICROSCOPIC OBSERVATION REVEALED GOOD ADHESIVE COVERAGE ON THE UNDERSIDE OF BOTH RETAINERS; HOWEVER, STRINGS OF ADHESIVE WERE FOUND ON THE UNDERSIDE OF THE RETAINER OF THE SEALED SAMPLE WHEN AN ATTEMPT WAS MADE TO REMOVE IT FROM THE PAD. THIS SUGGESTS THAT THE ADHESIVE BETWEEN THE RETAINER AND PAD MAY NOT HAVE BEEN FULLY CURED. THE 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 JUEP2260 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUEP2260) HAVE BEEN REPORTED FROM MULTIPLE FACILITIES IN DENMARK. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11

Description of Event or Problem

IT WAS REPORTED THE PLASTIC CLAMPS ON THE STATLOCK DEVICE FALLS OFF THE BAND AID SO THE PICC CATHETER IS AT RISK FOR SLIDING OUT OFF THE PATIENT BECAUSE IT IS NOT FIXED. SO PLASTIC CLAMPS ARE NOT FIXED CORRECT ON THE BAND AID. NO OTHER INFORMATION WAS PROVIDED. 04/21/2021- TWO DEVICES WERE RETURNED. THIS REPORT ADDRESSES THE FIRST DEVICE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEP2260 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. DEVICE NOT RETURNED FOR EVALUATION.

Description of Event or Problem

IT WAS REPORTED THE PLASTIC CLAMPS ON THE STATLOCK DEVICE FALLS OFF THE BAND AID SO THE PICC CATHETER IS AT RISK FOR SLIDING OUT OFF THE PATIENT BECAUSE IT IS NOT FIXED. SO PLASTIC CLAMPS ARE NOT FIXED CORRECT ON THE BAND AID. NO OTHER INFORMATION WAS PROVIDED.