MAUDE Adverse Event Report: UNKNOWN SYRINGE 3 ML 25G 5/8" L/L 9570; SYRINGE, PISTON

Device Problems Device Difficult to Setup or Prepare (1487); Material Twisted/Bent (2981)

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

Event Type  malfunction  

Event Description

Spontaneous call from patient who reported that when he inserted the needle into the vial with the medication, the syringe needle tip bent.No missed dose or adverse event reported; unknown if available for return; unknown if md aware.No further information provided.Syringe needles used to inject somavert at above dose/frequency.Reported to (b)(6) by: patient/caregiver.

• Brand Name: SYRINGE 3 ML 25G 5/8" L/L 9570
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16264737
• MDR Text Key: 308524870
• Report Number: MW5114559
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male