STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE; THE MANUFACTURING LOT NUMBER THAT WAS PROVIDED IS INCORRECT.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER: WHEN THE OLD BANDAGE WAS LOOSENED, PART OF THE STATLOCK DEVICE SUDDENLY CAME OFF AND THE PICC ALMOST SLIPPED OUT. CONSEQUENCES: NONE. PICC ALMOST SLIPPED OUT, BUT COULD STILL BE STOPPED

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER: WHEN THE OLD BANDAGE WAS LOOSENED, PART OF THE STATLOCK DEVICE SUDDENLY CAME OFF AND THE PICC ALMOST SLIPPED OUT. CONSEQUENCES: NONE. PICC ALMOST SLIPPED OUT, BUT COULD STILL BE STOPPED.

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 BATCH HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, SAMPLE ANALYSIS AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DETACHED STATLOCK RETAINER IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. ONE STATLOCK SECUREMENT DEVICE WAS RETURNED WITHOUT PRODUCT PACKAGING. THE RETAINER WAS COMPLETELY DETACHED FROM THE BASE PAD. MICROSCOPIC OBSERVATION OF THE RETAINER REVEALED ADHESIVE TO BE PRESENT ALONG THE BOTTOM PORTION OF THE DEVICE. IMPRESSIONS OF THE RETAINER BEING PRESSED ONTO THE BASE PAD WERE VISIBLE. THE REVIEW OF THE MANUFACTURING RECORDS CONDUCTED BY THE MANUFACTURING FACILITY DETERMINED THE CURRENT MANUFACTURING CONTROLS TO BE ADEQUATE AS TO DETECT AND SEGREGATE ANY NONCONFORMING UNIT. THE CONDITION OF THE STATLOCK PRIOR TO HANDLING AND USE IS UNKNOWN. BASED ON THE CONDITION OF THE RETURNED SAMPLE POSSIBLE CONTRIBUTING FACTORS INCLUDE DAMAGE DURING HANDLING OR PULLING ON THE RETAINER. SINCE THE RETAINER WAS FOUND TO BE DETACHED, THE COMPLAINT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H11.