FDA Adverse Event
Malfunction
Summary report: N
BD PRECISIONGLIDE NEEDLE 16G X 1
MDR report key: 13506609
·
Received February 9, 2022
Report
- Report Number
- MW5107362
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Date of Event
- February 7, 2022
- Report Date
- February 8, 2022
- Manufacturer
- BD
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PHARMACY TECHNICIAN NOTED DEBRIS IN A BD PRECISIONGLIDE NEEDLE 16G X 1 IN NEEDLE HUB. LOT 1210583. REF 305197. PRODUCT WAS NOT USED. FDA SAFETY REPORT ID # (B)(4).
Description of Event or Problem · 0
PHARMACY TECHNICIAN NOTED DEBRIS IN A BD PRECISIONGLIDE NEEDLE 16G X 1 IN NEEDLE HUB. LOT 1210583. REF 305197. PRODUCT WAS NOT USED. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76082 | BD PRECISIONGLIDE NEEDLE 16G X 1 | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BD | REF 305197 | 1210583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |