MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that a syringe 0.5ml 31ga 8mm 10bag 500 pl/wg separated from the hub during use.The following was reported by the initial reporter: "it was reported that needle hub separated inside of shield.Verbatim: consumer reported that the needle hub separated inside of the shield.".
Event or Problem Description
It was reported that a syringe 0.5ml 31ga 8mm 10bag 500 pl/wg separated from the hub during use.The following was reported by the initial reporter: "it was reported that needle hub separated inside of shield.Verbatim: consumer reported that the needle hub separated inside of the shield.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/9/2021.H.6.Investigation: customer returned two syringes with no pouch for identification.Both feature 0.5ml graduation markings.Both syringes feature their needle shield and hub having separated from the barrel.The hubs have become lodged inside the shields.There is no damage to either the connectors at the distal tips of the barrels or their respective needle hubs.The plunger caps were not returned but no signs of use were observed.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 zero (0) notifications noted that pertained to the complaint.Root cause for this defect cannot be determined.Capa#1630423 was initiated.H3 other text : see h.10.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11346420
• Report Number: 1920898-2021-00195
• Device Sequence Number: 5036159
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 02/09/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1