BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
Report
- Report Number
- 9617032-2024-01900
- Event Type
- Malfunction
- Date Received
- December 6, 2024
- Date of Event
- November 11, 2024
- Report Date
- December 9, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- FMI
- UDI-DI
- 30382903688358
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 05-DEC-2024. INVESTIGATION SUMMARY: MATERIAL #: 368835. LOT/BATCH #: 4242686. BD RECEIVED 18 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WAS OBSERVED. THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR MISSING SLEEVE WITH THE INCIDENT LOT WAS OBSERVED IN 7 OF THE SAMPLES. THE OTHER 11 SAMPLES WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE FAILURE MODE OF SLEEVE LEAKAGE WAS NOT OBSERVED. ADDITIONALLY, 150 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING SLEEVE WAS OBSERVED IN 30 RETENTION SAMPLES. TEN (10) ADDITIONAL RETENTION SAMPLES WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE FAILURE MODE OF SLEEVE LEAKAGE WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODES MISSING SLEEVE AND SLEEVE LEAKAGE. BD DETERMINED THAT THE ROOT CAUSE OF THE MISSING SLEEVE FAILURE MODE WAS ATTRIBUTED TO OPERATOR ERROR IN THE LINE PURGING PROCESS. A QUALITY ALERT WAS CIRCULATED WITH ALL FACULTY INVOLVED TO ENSURE PROPER LINE CLEARANCE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE SLEEVE LEAKAGE FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE. SOME DEVICES WERE ALSO FOUND WITHOUT THE SLEEVE COVERING THE NON-PATIENT CANNULA. THIS OCCURRED WITH FIVE (5) DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
IT WAS REPORTED WHILE USING A BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD LEAKED FROM THE NON-PATIENT END OF THE DEVICE. SOME DEVICES WERE ALSO FOUND WITHOUT THE SLEEVE COVERING THE NON-PATIENT CANNULA. THIS OCCURRED WITH FIVE (5) DEVICES. THERE WAS NO REPORT OF ADVERSE IMPACT TO PATIENTS OR USERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2516285 | BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER | BLOOD SPECIMEN COLLECTION DEVICE | FMI | BECTON, DICKINSON AND COMPANY (BD) | 4242686 | 30382903688358 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |