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U.S. Department of Health and Human Services

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

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UNKNOWN SYRINGE 3 ML 25G 5/8" L/L 9570; SYRINGE, PISTON Back to Search Results
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.
 
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Brand Name
SYRINGE 3 ML 25G 5/8" L/L 9570
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
UNKNOWN
MDR Report Key16264737
MDR Text Key308524870
Report NumberMW5114559
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/27/2023
Patient Sequence Number1
Patient SexMale
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