MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PEN NEEDLE 23G X 7MM; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	4736989
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Investigation summary : exec summary - no physical device samples were returned.Nine (09) pictures were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Following the pictures' review bdm-ps confirms the reported condition on the product.A review of the complaint lot history check was performed and this is the 1st.Related complaint for damaged or deformed hub on this lot #.No non-conformances were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
Event or Problem Description
It was reported that 1 bd pen needle 23g x 7mm had product damage issues.The following information was provided by the initial reporter : the reported package defect where the film of the protective seal on the needle is still attached and the plastic part inside is deformed.

• Brand Name: BD PEN NEEDLE 23G X 7MM
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13285768
• Report Number: 1920898-2022-00003
• Device Sequence Number: 14688710
• Product Code: FMI
• UDI-Device Identifier: 00382904736989
• UDI-Public: 00382904736989
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2022

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: 01/31/2024
• Device Model Number: 4736989
• Device Catalogue Number: 47369802
• Device Lot Number: 8275681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2018
• 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