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: (b)(6) 2023 sample: yes cl.

Manufacturer Narrative

Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Capa pr1630423 was opened to address hub separates and was closed effective on 05 october 2022.

• 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: 18570355
• MDR Text Key: 333558975
• Report Number: 1920898-2024-05014
• 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