MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 29GA 12.7MM 100 BX 1200 USA; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	328203
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported found 2 needles that broke at the base of the needle- while injecting.Caller is bed bound.Lot # 2228002 catalog# 328203 date of event 12/11/2023 discard needle - went to hospital for xray.They could not locate the needle at stomach injection site.Denied reuse.Does not pinch up skin for injections.Has an aide that assists with injections date of event 12/14/2023 awaiting sample has not received medical attention for this event as of yet.Denied reuse - does not pinch up skin for injections.Has an aide that assists with injections.Caller is a retired health care professional.Dc.
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: PEN NDL 29GA 12.7MM 100 BX 1200 USA
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
• Manufacturer (Section G): BECTON DICKINSON
• Manufacturer Contact: avital merl
• MDR Report Key: 18472337
• Report Number: 9616656-2024-05013
• Device Sequence Number: 6407936
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: (01)00382903282036
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• 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): 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 328203
• Device Lot Number: 2228002
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown