MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG; PISTON SYRINGE

Catalog Number	324910
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: unknown batch#: 3348051 it was reported that the bd syringe 0.3ml 31ga 6mm halfunit 10bag had foreign matter.The following information was provided by the initial reporter: "customer purchased syringes from brookshire brothers pharmacy and states that 3 of the syringes had a liquid in them." lot: 3348051 unable to provide material number qty: (b)(4).Verbatim: complaint received via email(s) attached.Complaint received by phone call on 03-may-2024.Customer purchased syringes from brookshire brothers pharmacy and states that 3 of the syringes had a liquid in them.Lot: 3348051 unable to provide material number qty: (b)(4).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG
• Common Device Name: PISTON 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19397565
• Report Number: 1920898-2024-00122
• Device Sequence Number: 7762671
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: (01)00382903249107
• 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
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: Other
• Device Catalogue Number: 324910
• Device Lot Number: 3348051
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown