BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE W/ PRE-ATTACH HOLDER
Report
- Report Number
- 1024879-2023-00299
- Event Type
- Malfunction
- Date Received
- May 16, 2023
- Date of Event
- April 21, 2023
- Report Date
- May 31, 2023
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FMI
- UDI-DI
- 50382903686501
- PMA / PMN Number
- K982541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES, D9: RETURNED TO MANUFACTURER ON: 2023-05-23. H.6. INVESTIGATION SUMMARY: BD RECEIVED 46 SAMPLES (11 FROM LOT 2245305, 11 FROM LOT 2245312, 12 FROM LOT 2160115, AND 12 FROM LOT 2251982. NO SAMPLES FROM LOT 2145499) AND 1 PHOTO OF LOT 2245312 FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. THE NATURE AND ORIGIN OF THE FOREIGN MATTER COULD NOT BE DETERMINED FROM THE PHOTO. THE FAILURE MODE OF DULL NEEDLE POINT WAS NOT OBSERVED FROM THE PHOTO. THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODES FOR FOREIGN MATTER AND DULL NEEDLE POINT WITH THE INCIDENT LOT WAS NOT OBSERVED IN ANY OF THE SAMPLES. ADDITIONALLY, 30 RETENTION SAMPLES OF LOT 2145499 FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUES OF FOREIGN MATTER AND DULL NEEDLE POINT WERE 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 MODE FOREIGN MATTER FOR LOT 2245312. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE DULL NEEDLE POINT FOR LOT 2245312. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODES FOREIGN MATTER AND DULL NEEDLE POINT FOR LOTS 2145499, 2245305, 2160115, 2251982. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. H3 OTHER TEXT : SEE H.10.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2245305. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. H.4. DEVICE MANUFACTURE DATE: 2022-09-02. D.4. MEDICAL DEVICE LOT #: 2251982. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. H.4. DEVICE MANUFACTURE DATE: 2022-09-30. D.4. MEDICAL DEVICE LOT #: 2245312. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-08-31. H.4. DEVICE MANUFACTURE DATE: 2022-09-22. D.4. MEDICAL DEVICE LOT #: 2145499. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31. H.4. DEVICE MANUFACTURE DATE: 2022-06-09. D.4. MEDICAL DEVICE LOT #: 2160115. D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-06-30. H.4. DEVICE MANUFACTURE DATE: 2022-06-30. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE W/ PRE-ATTACH HOLDER THERE WAS FOREIGN MATTER ON THE DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE IS SOME EXTRA WHITE IN NEEDLES (SILICON)."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE W/ PRE-ATTACH HOLDER THERE WAS FOREIGN MATTER ON THE DEVICE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE IS SOME EXTRA WHITE IN NEEDLES (SILICON).".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1165858 | BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE W/ PRE-ATTACH HOLDER | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON, DICKINSON & CO., (BD) | 368650 | SEE H.10 | 50382903686501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |