FDA Adverse Event
Malfunction
Summary report: N
BD PLASTIPAK LUER-LOK
MDR report key: 24972761
·
Received April 23, 2026
Report
- Report Number
- 1213809-2026-00218
- Event Type
- Malfunction
- Date Received
- April 23, 2026
- Date of Event
- March 30, 2026
- Report Date
- April 1, 2026
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903095704
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED THAT BD SYRINGE 3ML LL W/NDL 25X5/8 RB HAD LEAKAGE. COMPLAINT VIA EMAIL. PLEASE REVIEW THE BRANDED PRODUCT QUALITY COMPLAINT INVOLVING (B)(6) ITEM# 9872220 FROM OUR CUSTOMER. THE CUSTOMER HAS BEEN ISSUED A RETURN LABEL TO RETURN THE PRODUCT FOR EVALUATION. PRODUCT DESCRIPTION: SYRINGES W/NEEDLE LL DISP 3CC. HSI ITEM NUMBER: 9872220. MANUFACTURER PART NUMBER: 309570. LOT OR SERIAL NUMBER: LOT NUMBER: 5345078 ISSUES: THE OFFICE RECEIVED SYRINGES THAT ARE LEAKING PER FSC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 82836 | BD PLASTIPAK LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 5345078 | 00382903095704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |