STATLOCK SLIDING POST CRESCENT PAD SKIN PREP

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 LOT HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), LABELING, APPLICABLE MANUFACTURING RECORDS, RETURNED PHYSICAL SAMPLES, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF DIFFICULTY CLOSING THE STATLOCK LATCH WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS TWO STATLOCK PICC PLUS CATHETER SECUREMENT DEVICES. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE CAUSED BY PUSHING THE SECUREMENT TAB AT AN ANGLE WHILE ATTEMPTING TO CLOSE THE DEVICE. THIS ISSUE CAN BE AVOIDED BY CENTERING THE THUMB ABOUT THE MIDDLE OF THE TAB AND PRESSING DIRECTLY DOWNWARDS. THE RETURNED PRODUCT SAMPLES WERE EVALUATED AND THE FOLLOWING OBSERVATIONS WERE MADE WHICH WERE CONSISTENT WITH THIS FAILURE TYPE: AN ATTEMPT TO TEST THE FUNCTIONALITY OF THE LOCK WAS UNSUCCESSFUL AND THE TWO TOP RIGHT LATCHES WERE OBSERVED TO BE MISALIGNED WITH THE CATCH BASE; THE ASSOCIATED RIGHT TAB HINGES EXHIBITED AN OFF-AXIS CREASE AND CONTAINED DAMAGE OUTSIDE THE HINGE CREASE; THE TAB LATCHES WERE OBSERVED TO BE BENT AND HAD PLASTIC DEFORMATION WHICH WAS SEEN AT THE POINT OF CONTACT WITH THE CATCH. ¿ THE TAB CATCHES EXHIBITED PLASTIC DEFORMATION AT THE POINT OF CONTACT WITH THE LATCH THIS FAILURE TYPE WAS RECREATED IN THE LABORATORY USING NON-COMPLAINANT SAMPLES BY CLOSING THE TAB AT AN ANGLE, OR BY PRESSING OUTSIDE THE CENTER OF THE TAB, AND THE FEATURES OBSERVED ON THE LABORATORY SAMPLES WERE SIMILAR TO THOSE ON THE RETURNED COMPLAINANT SAMPLE. THE NATURE OF THE DAMAGE OBSERVED ON THE LATCH, AND THEIR POINTS OF CONTACT ON THE CATCH BASE AS WELL AS THE CHARACTERISTICS OF THE HINGE DAMAGE, ARE EVIDENCE THAT THE DAMAGE WAS CAUSED BY MISALIGNMENT OF THE DOORS WHEN CLOSING THE DEVICE. PUSHING THE TAB AT AN ANGLE CAN CAUSE THE LATCH TO MISS THE CATCH BASE AND CAN PERMANENTLY BEND THE LATCH. AN EXAMINATION OF THE SAMPLE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. A LOT HISTORY REVIEW (LHR) OF JUES2195 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUES2195) HAVE BEEN REPORTED FROM THE SAME FACILITY IN THE NETHERLANDS. H3 OTHER TEXT: EVALUATION FINDINGS ARE IN SECTION H11.

Description of Event or Problem

IT WAS REPORTED THE STATLOCK CLIPS OPEN. NO OTHER INFORMATION WAS PROVIDED. TWO DEVICES WERE RETURNED. THIS REPORT ADDRESSES THE FIRST DEVICE.

Description of Event or Problem

IT WAS REPORTED THE STATLOCK CLIPS OPEN. NO OTHER INFORMATION WAS PROVIDED. TWO DEVICES WERE RETURNED. THIS REPORT ADDRESSES THE FIRST DEVICE.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUES2195 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THE STATLOCK CLIPS OPEN. NO OTHER INFORMATION WAS PROVIDED.