STATLOCK PICC PLUS CRESCENT SLIDING POST

Description of Event or Problem

IT WAS REPORTED THAT ONE WING OF THE STATLOCK DEVICE DOES NOT STAY CLOSED. NO OTHER INFORMATION WAS PROVIDED.

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, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT THAT ONE WING OF THE STATLOCK STABILIZATION DEVICE WOULD NOT STAY CLOSED WAS CONFIRMED, BUT THE EXACT CAUSE COULD NOT BE DETERMINED. ONE STATLOCK WAS RECEIVED IN OPEN PACKAGING. THE ADHESIVE LINER HAD NOT BEEN REMOVED FROM THE SUBSTRATE. ONE SIDE OF THE RETAINER WAS CLOSED. THE DOOR ON THE OTHER SIDE OF THE RETAINER WAS OPEN AND ONE SECUREMENT LATCH WAS MISSING. A MICROSCOPIC EXAMINATION REVEALED THAT THE MISSING SECUREMENT LATCH WAS BROKEN FROM THE WING. THE HINGE EXHIBITED A CREASE, WHICH INDICATES THAT THE DOOR HAD BEEN MOVED FROM ITS OPEN POSITION. THIS TYPE OF DAMAGE CAN OCCUR IF THE DOORS ARE MISALIGNED WHEN LOCKING THE RETAINER, WHICH CAN CAUSE THE SECUREMENT LATCH TO BEND. ATTEMPTS TO STRAIGHTEN THE SECUREMENT LATCH CAN CAUSE IT TO BREAK OFF; HOWEVER, THE EXACT MECHANISM OF DAMAGE COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEW2307 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT ONE WING OF THE STATLOCK DEVICE DOES NOT STAY CLOSED. NO OTHER INFORMATION WAS PROVIDED.