MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD 0.5ML SYRINGE

Model Number	329407
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 2 bd 0.5ml syringes experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported finding 2 syringes needle shields and hubs laying in the bag.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.
Event or Problem Description
It was reported that 2 bd 0.5ml syringes experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported finding 2 syringes needle shields and hubs laying in the bag.
Event or Problem Description
It was reported that 2 bd 0.5ml syringes experienced hub separation from the device.The following information was provided by the initial reporter: consumer reported finding 2 syringes needle shields and hubs laying in the bag.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 9343434.D.4.Medical device expiration date: 12/31/2024.H.4.Device manufacture date: 12/9/2019.D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/6/2022.H.6.Investigation: customer returned (3) loose 0.5ml bd insulin syringes from lot# 9343434.The consumer reported 2 syringes where the needle shield and hub were laying in the bag.The returned syringes were examined, and it was observed that all three exhibited a broken barrel tip.A broken barrel tip was found lodged inside two detached needle hub/shield assemblies that were returned.A review of the device history record was completed for batch# 9343434.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Therefore, root-cause cannot be determined.H3 other text : see h.10.

• Brand Name: BD 0.5ML SYRINGE
• Common Device Name: SYRINGE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12954401
• Report Number: 1920898-2021-01281
• Device Sequence Number: 4291868
• Product Code: FMF
• UDI-Device Identifier: 00382903294077
• UDI-Public: 00382903294077
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2022

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 Model Number: 329407
• Device Catalogue Number: 329407
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 01/27/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/05/2022; 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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