MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL; Syringe, piston

Model Number 328509

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2023

Event Type  malfunction  

Event Description

Consumer reported when she removed the needle shield, the needle and hub separated and is stuck inside the needle shield.Stated, there is no expiration date on the bag she's using and does not know how old the syringes are.1 syringe affected.Lot: 0083446.Catalog: 328509.Date of event: 2023-12-26.Sample: yes cl.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL
• Type of Device: Syringe, piston
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18570719
• MDR Text Key: 333602572
• Report Number: 1920898-2024-05012
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311762
• UDI-Public: 00681131311762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328509
• Device Lot Number: 0083446
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1