MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL; PISTON SYRINGE

Model Number	328506
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
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 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 syringe 1.0ml 31ga 8mm 10bag 500 wal had a molding defect.The following information was provided by the initial reporter: material no.328506, batch no.0280937.It was reported that barrels are bent or melted and needles are dull.
Event or Problem Description
It was reported that syringe 1.0ml 31ga 8mm 10bag 500 wal had a molding defect.The following information was provided by the initial reporter: material no.328506 batch no.0280937.It was reported that barrels are bent or melted and needles are dull.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch#: 0280937.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.

• Brand Name: SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11341482
• Report Number: 1920898-2021-00189
• Device Sequence Number: 5036156
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• 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,Followup
• Report Date (Section B): 03/16/2021

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: 10/31/2025
• Device Model Number: 328506
• Device Catalogue Number: 328506
• Device Lot Number: 0280937
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1