FDA Adverse Event
Malfunction
Summary report: N
SAFTYGLIDE HYPODERMIC NEEDLE 25 GAUGE 1"
MDR report key: 17498928
·
Received August 9, 2023
Report
- Report Number
- MW5122873
- Event Type
- Malfunction
- Date Received
- August 9, 2023
- Date of Event
- August 2, 2023
- Report Date
- August 6, 2023
- Manufacturer
- BECTON DICKINSON AND COMPANY
- Product Code
- FMI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
RN STOCKED NEEDLES IN IMMUNIZATION ROOM WITH NEW BOX/LOT. LPN RETRIEVED NEEDLES TO ADMINISTER VACCINES. WHEN PREPARING VACCINES FOR ADMINISTRATION, LPN NOTICED THAT THE NEEDLES WOULD NOT PRIME DUE TO OCCLUSION. LPN ALERTED CLINICAL COORDINATOR WHO REMOVED ALL AFFECTED NEEDLES FROM STOCK, ALERTED CLINICAL TEAM OF ISSUE AND TO BE AWARE OF OTHER POTENTIALLY AFFECTED NEEDLES. MCKESSON SAFETY HYPODERMIC NEEDLE GLIDE 25G X 1 IN LOT: 2153548, EXPIRATION: 5/31/2027. MCKESSON IRVING, TX 75039 US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1049016 | SAFTYGLIDE HYPODERMIC NEEDLE 25 GAUGE 1" | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON AND COMPANY | 2153548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |