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

Model Number	928856
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the syringe 1.0ml 31ga 8mm 10bag 500 pl/wg experienced foreign matter contamination.The following information was provided by the initial reporter: (b)(6) consumer removing a new syringe from package of 10 and finding what she described as "water" in the barrel.The syringe is unused.1 syringe affected.Catalog: 928856, lot: 0125633, date of event: (b)(6) 2020.
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 # 0125633.All inspections and challenges were performed per the applicable operations qc specifications.There were two notifications [200893686, 200893521] noted that did not pertain to the complaint.
Event or Problem Description
It was reported that the syringe 1.0ml 31ga 8mm 10bag 500 pl/wg experienced foreign matter contamination.The following information was provided by the initial reporter: walgreens consumer removing a new syringe from package of 10 and finding what she described as "water" in the barrel.The syringe is unused.1 syringe affected.Catalog: 928856.Lot: 0125633.Date of event: (b)(6) 2020.

• Brand Name: SYRINGE 1.0ML 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: 10789146
• Report Number: 1920898-2020-01532
• Device Sequence Number: 4134801
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/26/2021

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: 928856
• Device Catalogue Number: 928856
• Device Lot Number: 0125633
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 03/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1