MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320551
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
2 pen needles affected by event.
Event or Problem Description
Consumer reported when injecting with the 2nd gen pen needles only, the needle really hurts going into the site and coming out of the site.Does a flow check with each injection.Dc.Consumer reported - 2 pen needles hard to attach onto his pen.Lot#: 1173074, catalog#: 320551 - sample pack, date of event: 03-22-2024, sample status: awaiting sample.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND; EI
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 19111738
• Report Number: 9616656-2024-05249
• Device Sequence Number: 15231923
• Product Code: FMI
• UDI-Device Identifier: 30382903205517
• UDI-Public: 30382903205517
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2026
• Device Model Number: 320551
• Device Lot Number: 1173074
• 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: 03/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown