BD SYRINGE
Report
- Report Number
- 3003152976-2026-00124
- Event Type
- Malfunction
- Date Received
- March 4, 2026
- Date of Event
- February 26, 2026
- Report Date
- March 3, 2026
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- UDI-DI
- 00382903020553
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD SYRINGE 20ML LL NS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 302055, BATCH#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY STATE MOISTURE IN SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. WE WERE NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING MOISTURE IN SYRINGE. PLEASE SEE THE BELOW DETAILS REGARDING THE REPORTED ISSUE. IF IT IS INDICATED THAT A SAMPLE IS AVAILABLE, PLEASE PROVIDE SHIPPING INSTRUCTIONS WITHIN 30 DAYS OR THE SAMPLE WILL BE DISPOSED OF. MEDLINE COMPLAINT#: (B)(4). DEFECT DESCRIPTION: MOISTURE IN SYRINGE. MEDLINE PART#: 153240. PRODUCT DESCRIPTION: SYRINGE 20ML LL BNS. VENDOR PART#: 302055. LOT#: UNKNOWN. DATE REPORTED: 1/28/2026. SAMPLE RECEIVED: YES. RESPONSE NEEDED: YES, INCIDENT REPORTED TO THE FDA AS MDR-30 DAY. REFERENCE NO. 1423395-2026-00026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157430 | BD SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | UNKNOWN | 00382903020553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |