FDA Adverse Event
Malfunction
Summary report: N
BD SYRINGE 3ML LL 200 S/C
MDR report key: 20678422
·
Received November 13, 2024
Report
- Report Number
- 1920898-2024-00150
- Event Type
- Malfunction
- Date Received
- November 13, 2024
- Date of Event
- March 1, 2024
- Report Date
- January 22, 2025
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 30382903096573
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IMDRF CODES MUST BE UPDATED.
Additional Manufacturer Narrative · 0
B.3. 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
IMDRF CODES MUST BE UPDATED.
Description of Event or Problem · 0
MATERIAL#: 309657, BATCH#: 3121510. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. RN (REGISTERED NURSE) OPENED A BD PLASTI-PAK 3 ML LUER LOCK STERILE SYRINGE, LOT: 3121510, FOR USE WITH A PATIENT. A DARK PARTICLE THAT LOOKED LIKE MOLD WAS NOTED INSIDE THE SYRINGE WHERE THE NEEDLE CONNECTS TO THE SYRINGE. SYRINGE WAS SAVED. PACKAGING WAS NOT SAVED. PRODUCT#: 309657, LOT#: 3121510.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2069558 | BD SYRINGE 3ML LL 200 S/C | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 3121510 | 30382903096573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |