FDA Adverse Event Malfunction Summary report: N

25GX1IN HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE

MDR report key: 17143553 · Received June 15, 2023

Report

Report Number
MW5118433
Event Type
Malfunction
Date Received
June 15, 2023
Date of Event
June 12, 2023
Report Date
June 13, 2023
Manufacturer
SMITHS MEDICAL ASD, INC.
Product Code
FMI
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
KY, US
Reporter Occupation
117
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PROVIDER WAS ADMINISTERING A REQUESTED VACCINE. PATIENT REQUESTED TDAP VACCINATION FOR TRAVEL/NEW BABY AT HOME. VACCINATION INFORMATION: TDAP BOOSTRIX, MANUFACTURER GSK, VACCINE LOT #H242K, EXP 6/92023. TDAP VACCINATION IS 0.5 ML SINGLE USE VIAL, IM INJECTION. PROVIDER ATTACHED 25GX1IN HYPODERMIC NEEDLE TO VIAL. NEEDLE INFORMATION: SMITHS MEDICAL ASD, HYPODERMIC NEEDLE-PRO, EDGE SAFETY DEVICE, REFERENCE # 402510, 25GX1IN, LOT # 4246712, EXP 02-02-2027. PROVIDER INJECTED NEEDLE INTRAMUSCULARLY INTO PATIENT'S LEFT DELTOID AND WHILE INJECTING VACCINE, THERE WAS A SMALL CRACK IN PLASTIC BASE OF NEEDLE CONNECTING TO VACCINE LUER-LOCK. THE CONTENTS OF THE VACCINE DRIPPED OUT OF THE CRACK IN THE NEEDLE ONTO THE FLOOR. PROVIDER IS UNSURE ON HOW MUCH OF THE TDAP VACCINE WAS ACTUALLY ADMINISTERED TO PATIENT AND DOCUMENTED IT AS A PARTIAL ADMINISTRATION. PATIENT DID NOT EXPERIENCE ANY ADVERSE SIDE EFFECTS. NO RELEVANT TESTS OR LABORATORY DATA REQUIRED. PATIENT WAS EDUCATED TO OBTAIN VACCINE AT A DIFFERENT CLINIC DUE TO CLINIC BEING OUT OF VACCINE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
709505 25GX1IN HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI SMITHS MEDICAL ASD, INC. 402510 4246712

Patients

Seq Age Sex Outcome Treatment
1 24 YR Male