SITE SCRUB IPA STERILE

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) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

Description of Event or Problem

IT WAS REPORTED THE SITE SCRUB IN THE CAP CHANGE KIT WAS DRY. 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 OF A DRY SITE-SCRUB IS INCONCLUSIVE DUE TO POOR SAMPLE CONDITION. THREE SITE-SCRUB IPA DEVICES WERE RETURNED FOR EVALUATION. THE PRODUCT LIDS INDICATED LOT: JUEY1066. THE THREE DEVICES CONTAINED PARTIALLY PEELED OPEN LIDS. MICROSCOPIC OBSERVATION OF THE PEELED REGIONS REVEALED EVIDENCE OF A SEAL BEING PRESENT. THE SITE-SCRUBS FOAM SPONGE APPEARED TO BE DRIED OUT. THE CONDITION OF THE LID SEALS PRIOR TO HANDLING AND USE ARE UNKNOWN; THEREFORE, THE ROOT CAUSE AND CONTRIBUTING FACTORS OF THE REPORTED ISSUE COULD NOT BE DETERMINED. NO OTHER SIMILAR COMPLAINTS WERE REPORTED FOR THE IMPLICATED LOT. A REVIEW OF THE MANUFACTURING QUALITY AND INSPECTION RECORDS FOR THE IMPLICATED LOT FOUND NO POTENTIALLY RELATED ISSUES DURING MANUFACTURING AND ASSEMBLY OF THAT PRODUCT LOT. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. THE COMPLAINT OF A DRY SITE-SCRUB IPA DEVICE COULD NOT BE INDEPENDENTLY CONFIRMED WITHOUT EVALUATION OF SEALED SAMPLES; HOWEVER, THE REPORT OF A DRY COMPONENT HAS BEEN DOCUMENTED AND INCLUDED IN COMPLAINT TRENDING. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A LOT HISTORY REVIEW (LHR) OF JUEY1066 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THE SITE SCRUB IN THE CAP CHANGE KIT WAS DRY. NO OTHER INFORMATION WAS PROVIDED.