SITE SCRUB IPA STERILE

Description of Event or Problem

IT WAS REPORTED THE BARD SITE SCRUB COMPONENT WITHIN THE KIT HAS BEEN COMING UP DRY. NO DELAY IN PROCEDURES, ANOTHER KIT WOULD BE OPENED AND USED OR INJURY/MEDICAL TREATMENT AS A RESULT. IT WAS STATED THIS OCCURRED AT LEAST THREE TIMES. NO OTHER INFORMATION REGARDING QUANTITY OR OCCURRENCES 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, 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 DRY SITE-SCRUB DEVICES WAS INCONCLUSIVE AS THE RETURNED SAMPLES WERE LOT SAMPLES WHERE THE PROBLEM COULD NOT BE REPRODUCED. TWENTY LOT SAMPLES OF UNOPENED SITE-SCRUB IPA DEVICES WERE RETURNED FOR EVALUATION OF THIS COMPLAINT. ALL DEVICES WERE LABELED WITH JUEV0549. IT WAS VERIFIED THAT THE LABELED EXPIRATION DATE (2023/11/28) HAD NOT PASSED. THE LIDS ON ALL SAMPLES WERE SLIGHTLY CONVEX AND PRESENTED RESISTANCE WHEN TOUCHED, INDICATING THAT THE SEALS WERE INTACT. NO DAMAGE WAS SEEN TO THE CANISTERS, LIDSTOCK, OR TO THE SEALS ON THE PACKAGES. THE SITE-SCRUB CONTAINERS WERE OPENED BY THE INVESTIGATOR, AND AN ATTEMPT WAS MADE TO CLEAN A NON-COMPLAINANT CATHETER HUB WITH THE SITE-SCRUB DEVICES. EXAMINATION OF THE HUB REVEALED LIQUID TRANSFER BETWEEN THE SITE-SCRUB DEVICES TO THE CATHETER HUB WHEN TESTING ALL SAMPLES. THE SAMPLES SMELLED OF IPA WHEN THE CANISTERS WERE OPENED AND WERE MOIST WHEN TOUCHED. ALL DEVICES WERE MOIST AND LIQUID TRANSFER WAS SEEN DURING FUNCTIONAL TESTING. AS THE FAILURE MODE COULD NOT BE REPRODUCED ON THE LOT SAMPLES AND THE ORIGINAL SAMPLES WERE NOT RETURNED FOR EVALUATION, THIS COMPLAINT WILL BE CONSIDERED INCONCLUSIVE AT THIS TIME. A REVIEW OF MANUFACTURING DOCUMENTS FOR THIS LOT/BATCH WAS CONDUCTED AND FOUND NO DISCREPANCIES OR ANOMALIES DURING THE MANUFACTURE OF THE SUBJECT LOT. THE PRODUCT MET SPECIFICATION AND THERE WAS NOTHING NOTED IN THE MANUFACTURING DOCUMENTS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUEV0549 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THE BARD SITE SCRUB COMPONENT WITHIN THE KIT HAS BEEN COMING UP DRY. NO DELAY IN PROCEDURES, ANOTHER KIT WOULD BE OPENED AND USED OR INJURY/MEDICAL TREATMENT AS A RESULT. IT WAS STATED THIS OCCURRED AT LEAST THREE TIMES. NO OTHER INFORMATION REGARDING QUANTITY OR OCCURRENCES WAS PROVIDED. THIS REPORT ADDRESSES THE FIRST OCCURRENCE.