STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL PAD

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUES1600 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THE STATLOCK DEVICE BROKE WHEN THE CATHETER WAS FIXED TO IT.

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, APPLICABLE PREVIOUS INVESTIGATION(S), APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A STATLOCK DEVICE THAT BROKE THE CATHETER WHEN FASTENED COULD NOT BE CONFIRMED FROM THE PHOTO THAT WAS RETURNED FOR EVALUATION AND IS INCONCLUSIVE. IN THE PHOTO THE RETURN LABEL AND STATLOCK DEVICE FOR LOT # JUES1600 CAN BE SEEN INSIDE OF A PLASTIC BAG. THE ADHESIVE LINING APPEARS TO BE CONNECTED TO THE BACK OF THE DEVICE BUT IS SLIGHTLY MISALIGNED. FROM THE PHOTO THERE ARE NO SIGNS OF DAMAGE THAT CAN BE SEEN. SINCE THE RETURNED PHOTO SHOWS NO DAMAGE AND THE DEVICE CANNOT BE SEEN CAUSING A BREAK IN THE CATHETER, THE COMPLAINT WAS INCONCLUSIVE. BASED ON THE DESCRIPTION OF THE REPORTED EVEN, POSSIBLE CONTRIBUTING FACTORS INCLUDE SECUREMENT TECHNIQUE AND INCOMPATIBLE COMPONENTS, HOWEVER THE ROOT CAUSE IS UNKNOWN. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11

Description of Event or Problem

IT WAS REPORTED THE STATLOCK DEVICE BROKE WHEN THE CATHETER WAS FIXED TO IT.