STATLOCK PICC PLUS CRESCENT SLIDING POST

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER "WE HAD AN INCIDENT WHERE THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM." ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THE LINE WAS INSERTED ON (B)(6) 2022. EVENT OCCURRED ON OCTOBER 13, 2022. DRESSING CHANGE LAST COMPLETED ON (B)(6) 2022. IT IS UNKNOWN IF THERE WAS A TEGADERM OVERTOP THE PICC LINE. THE LINE SNAPPED INTO THE STAT LOCK WHEN THE LINE CAME DISLODGED, AS THE ¿SNAP-IN¿ PIECE WAS STILL CONNECTED TO THE LINE.

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), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A STATLOCK RETAINER DETACHING FROM THE FOAM PAD IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. ONE STATLOCK PICC PLUS WAS RETURNED WITH OPEN PACKAGING INDICATING LOT: JUGN3039. THE LEFT SECTION OF THE RETAINER BASE WAS FOUND TO BE PARTIALLY DETACHED FROM THE FOAM PAD. THE RIGHT SECTION WAS STILL ADHERED. MICROSCOPIC INSPECTION BETWEEN THE DETACHED BASE REVEALED EVIDENCE OF ADHESIVE BEING PRESENT. THE REPORTED EVENT DESCRIPTION INDICATES THE DEVICE WAS IN USE FOR APPROXIMATELY THREE WEEKS. BASED ON THE CONDITION OF THE RETURNED SAMPLE AND INFORMATION PROVIDED, POSSIBLE CONTRIBUTING FACTORS INCLUDE EXTERNAL FORCES APPLIED TO THE RETAINER DURING USE. THE PRESENCE OF ADHESIVE ON THE RETAINER AND PAD AND A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY EVIDENCE TO SUGGEST A MANUFACTURING RELATED ROOT CAUSE. SINCE THE STATLOCK WAS FOUND TO BE PARTIALLY DETACHED, THE COMPLAINT IS CONFIRMED; HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED BY THE CUSTOMER "WE HAD AN INCIDENT WHERE THE STAT LOCK PLASTIC DETACHED AND A PICC WAS PULLED OUT 20CM."

Additional Manufacturer Narrative

THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUGN3039 SHOWED FIVE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.