MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS; Syringe, piston

Model Number 328411

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2024

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not available.

Event Description

Consumer reported needle break, stated that on 2-22-24 the needle broke off in the injection site.Consumer said that he went to the er and had x-rays done.He said a total of 8 needles were seen on the x-rays.Consumer said he is going to contact his attorney.Lot #: 3233260.Catalog #: 328411.Date of event: 2-22-24.Samples: discarded.

• Brand Name: SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
• 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: 18952364
• MDR Text Key: 338268570
• Report Number: 1920898-2024-05064
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: 00382908411035
• 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
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328411
• Device Lot Number: 3233260
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1