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

Model Number	928857
Medical Device Problem Codes	Failure to Deliver (2338); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 0.5ml 31ga 8mm experienced a case of hub separation from the device, and being unable to aspirate.The following information was provided by the initial reporter: stated, when she removed needle shield, needle hub separated.Stated 2 syringes would not draw insulin.
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/6/2022.H.6.Investigation: customer returned a single 0.5ml syringe with no other forms of identification.The syringe had its needle shield and hub separate from the barrel.The hub has become lodged inside the shield.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.No signs of use and no other defects found.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 two (2) notifications noted that did not pertain to the complaint.Capa#1630423 was initiated.H3 other text : see h.10.
Event or Problem Description
It was reported that bd syringe 0.5ml 31ga 8mm experienced a case of hub separation from the device, and being unable to aspirate.The following information was provided by the initial reporter: stated, when she removed needle shield, needle hub separated.Stated 2 syringes would not draw insulin.

• Brand Name: BD SYRINGE 0.5ML 31GA 8MM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13006766
• Report Number: 1920898-2021-01308
• Device Sequence Number: 11194286
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 12/28/2021

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?: 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: 11/19/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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