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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland PEN NDL 32G 4MM PRO 100 BOX 1200 US; Needle, Hypodermic, Single Lumen
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EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland PEN NDL 32G 4MM PRO 100 BOX 1200 US; Needle, Hypodermic, Single Lumen Back to Search Results
Model Number 320550
Medical Device Problem Code Failure to Deliver (2338)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
Consumer reported found about 2 dozen pen needles from two different lot number.Unknown amount on each lot #.Needles would not prime.Noticed after removed from pen the non patient end needle to be bent.Dc lot # 3017179 lot # 3025239 catalog# unknown - 32g 4mm 2nd gen date of event unknown sample status awaiting sample.
 
Additional Manufacturer Narrative
12 pen needles affected by event.
 
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Brand Name
PEN NDL 32G 4MM PRO 100 BOX 1200 US
Common Device Name
Needle, Hypodermic, Single Lumen
Manufacturer (Section D)
EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland
Manufacturer Contact
avital meri
300 kimball dr.
parsippany, NJ 07054
MDR Report Key50943940
Report Number3023359743-2026-00662
Device Sequence Number10446571
Product Code FMI
UDI-Device Identifier00382903205509
UDI-Public00382903205509
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K212015
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Type of Report Initial
Report Date (Section B) 09/30/2026
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
Device Model Number320550
Device Lot NumberUnknown
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/11/2024
Initial Report FDA Received Date09/30/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Patient Sequence Number1
Patient SexUnknown
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