MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM (100 COUNT)

Model Number	328203
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported that 2 pen needles clogged during injection.Informed caller of proper placement of non patient end needles.And to complete a flow check with all injections.
Additional Manufacturer Narrative
H3 other text : sample is not available.
Event or Problem Description
Consumer reported that 2 pen needles clogged during injection.Informed caller of proper placement of non patient end needles.And to complete a flow check with all injections.
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.Corrected data: b4: date of the initial medwatch report submission was december 14, 2023.

• Brand Name: BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM (100 COUNT)
• Common Device Name: BD ULTRA-FINE¿ ORIGINAL PEN NEEDLES 29G X 12.7MM (100 COUNT)
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr; parsippany, NJ 07054
• MDR Report Key: 18324290
• Report Number: 9616656-2023-05001
• Device Sequence Number: 7391442
• Product Code: FMI
• UDI-Device Identifier: 00382903282036
• UDI-Public: 00382903282036
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/23/2024

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 Model Number: 328203
• Device Lot Number: 2263456
• Was Device Available for Evaluation?: No
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown