MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary : exec summary - samples were received and an investigation was performed.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Samples returned - customer returned (2) loose 0.5ml insulin syringes.Consumer reported that the needle hub separated and stayed in the shield.The returned sample was examined, and it was observed that the cannula hub / shield assembly was separated from the barrel.No damage to the barrel tip was observed.Capa/sa - capa (b)(4) has been opened to address the issue.Dhr review - a review of the device history record was completed for batch# 0006836.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.
Event or Problem Description
It was reported that 1 bd syringe 0.5ml 31ga 8mm hub separated.The following information was provided by the initial reporter : the consumer reported that the needle hub separated and stayed in the shield.Date of event: unknown.Samples: available.

• Brand Name: SYRINGE 0.5ML 31GA 8MM
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11964908
• Report Number: 1920898-2021-00650
• Device Sequence Number: 4308763
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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: 01/31/2025
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 0006836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1