MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE

Catalog Number UNKNOWN

Device Problem Defective Device (2588)

Patient Problem Abrasion (1689)

Event Date 11/08/2023

Event Type  malfunction  

Event Description

It was reported that the bd needle was defective.The following information was provided by the initial reporter: "it was reported by customer that when rn went to administer the vaccine and as the needle came in contact with the patient, the needle bent without injecting and scratched the patient with approximately an 3/4" to inch scratch.It appears needle was defective at the base." lot #: 3206650.

Manufacturer Narrative

E.4.The initial reporter also notified the fda on 18-dec-2023.Medwatch report is mw5149442.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18610628
• MDR Text Key: 335077557
• Report Number: 1213809-2024-00042
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059011
• UDI-Public: (01)30382903059011
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951254
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 3206650
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1