STATLOCK PICC PLUS SLIDING POST PEDIATRIC PAD INCLUDES SKIN PREP

Additional Manufacturer Narrative

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 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 JUFS1082 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

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."

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

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), SAMPLE ANALYSIS, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DAMAGED STATLOCK DEVICE IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PICC PLUS PEDIATRIC STATLOCK DEVICE WITH A FOAM PAD AND ADJUSTABLE POSTS, ONE SKIN PREP PAD, AND ONE FOAM STRIP IN OPEN PACKAGE WERE RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION SHOWED THE RIGHT SIDE OF THE RETAINER OF THE STATLOCK DEVICE WAS TORN AWAY FROM THE PAD, AND THE LEFT SIDE OF THE PAD WAS TORN COMPLETELY OFF AND REPLACED ON THE BACK OF THE PAD. A MICROSCOPIC OBSERVATION REVEALED GOOD ADHESIVE COVERAGE ON THE EXPOSED UNDERSIDE OF THE RETAINER. THE FOAM OF THE PAD BENEATH THE RETAINER WAS OBSERVED TO HAVE BEEN TORN FROM THE PAD AND WAS NOW THOROUGHLY ADHERED TO THE RETAINER. WHILE THE CAUSE OF THE TORN PAD OF THE RETURNED SAMPLE COULD NOT BE DETERMINED, POSSIBLE CAUSES INCLUDE EXCESSIVE FORCE DURING APPLICATION, USE, OR HANDLING OF THE DEVICE.