BD PERISAFE¿ CATHETER CONNECTOR
Received Jan 8, 2019 · Event occurred Dec 19, 2018
Report 1625685-2018-00070 · MDR key 8227486
Device
Product problems
- Fluid/Blood Leak
- Unsealed Device Packaging
- Defective Component
- Packaging Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT BD PERISAFE¿ CATHETER CONNECTORS EXPERIENCED MULTIPLE ISSUES INCLUDING 100 CASES OF DEFECTIVE CONNECTOR/ADAPTOR, 100 CASES OF LEAKAGE, 100 CASES OF DAMAGED PACKAGING, 100 CASES OF POOR SEAL INTEGRITY CAUSING STERILITY CONCERNS, 100 CASES OF STERILITY QUESTIONED, AND 100 CASES OF DIFFICULTY OPENING PACKAGING. NO LOT NUMBERS WERE PROVIDED IN ASSOCIATION WITH THESE INCIDENTS.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. INVESTIGATION CONCLUSION: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT BD PERISAFE¿ CATHETER CONNECTORS EXPERIENCED MULTIPLE ISSUES INCLUDING 100 CASES OF DEFECTIVE CONNECTOR/ADAPTOR, 100 CASES OF LEAKAGE, 100 CASES OF DAMAGED PACKAGING, 100 CASES OF POOR SEAL INTEGRITY CAUSING STERILITY CONCERNS, 100 CASES OF STERILITY QUESTIONED, AND 100 CASES OF DIFFICULTY OPENING PACKAGING. NO LOT NUMBERS WERE PROVIDED IN ASSOCIATION WITH THESE INCIDENTS.