MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928858
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
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 is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the syringe 0.3ml 31ga 8mm 10bag 500 pl/wg would not aspirate during use.The following information was provided by the initial reporter: "consumer reported that the needles will not draw.Consumer does not re-use.".
Event or Problem Description
It was reported that the syringe 0.3ml 31ga 8mm 10bag 500 pl/wg would not aspirate during use.The following information was provided by the initial reporter: "consumer reported that the needles will not draw.Consumer does not re-use.".
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 0125322.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.H3 other text : see h10.

• Brand Name: SYRINGE 0.3ML 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: 11683261
• Report Number: 1920898-2021-00421
• Device Sequence Number: 4183383
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• 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): 05/07/2021

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: 05/31/2025
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 0125322
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/18/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1