MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. HYPODERMIC NEEDLE-PRO / NEEDLE WITH NEEDLE PROTECTION DE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 4290

Device Problems Fluid/Blood Leak (1250); Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

Needle used to administer im epinephrine had a hole at the base of the needle.When the rn finished pushing the medication into the muscle there was a pool of liquid on top of the skin.Unsure how much, if any, of the medication was actually administered.This was a critical medication for a patient experiencing a severe allergic reaction aeb wheezing and retractions.Iv medications (benadryl, pepcid, decadron) given at stat priority following the failed im injection.Patient appeared to improve greatly with iv medication administration.Fda safety report id # (b)(4).

• Brand Name: HYPODERMIC NEEDLE-PRO / NEEDLE WITH NEEDLE PROTECTION DE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11412242
• MDR Text Key: 235030793
• Report Number: MW5099770
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4290
• Device Lot Number: 4073942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR