FDA Adverse Event
Malfunction
Summary report: N
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
MDR report key: 25244113
·
Received May 21, 2026
Report
- Report Number
- 1024879-2026-00849
- Event Type
- Malfunction
- Date Received
- May 21, 2026
- Date of Event
- April 24, 2026
- Report Date
- April 27, 2026
- Manufacturer
- BECTON DICKINSON & CO (FRANKLIN LAKES)
- Product Code
- JKA
- UDI-DI
- 30382903686101
- PMA / PMN Number
- K243207
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K982541. 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 · 0
IT WAS REPORTED PRIOR TO USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, AN UNSPECIFIED NUMBER OF DEVICES WERE FOUND TO HAVE FOREIGN MATTER ON THE NEEDLE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 419588 | BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON DICKINSON & CO (FRANKLIN LAKES) | 5212625 | 30382903686101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |