MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL JELCO HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE SET; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number 4014199

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

Injection needle bent during intramuscular injection; second needle came apart form syringe while administering intramuscular injection.Fda safety report id# (b)(4).

• Brand Name: SMITHS MEDICAL JELCO HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE SET
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 14311992
• MDR Text Key: 291249365
• Report Number: MW5109576
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• 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: 05/04/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4014199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1