MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 300637

Device Problem Break (1069)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) : initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

Good morning i am emailing to report a faulty needle that one of our vets had the misfortune of using today.The needle broke off once inserted into a horse.As you can imagine, this is not an ideal situation.Please can you advise us of the course of action that needs to be taken? the needle in question is a 16g x 1 1/2, lot 220523.I look forward to your response.Many thanks luckily, on this occasion, there was no serious impact to the patient as the vet felt the needle snap and acted quickly and efficiently.

Manufacturer Narrative

Pr (b)(4) - follow up mdr for correction.After further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.After further review it was confirmed that the product was not used on a human but on an animal and completed.Mfr#: 3002682307- 2024-00054 is void as a result.

Event Description

No additional information.

• Brand Name: UNKNOWN BD NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18920283
• MDR Text Key: 337852825
• Report Number: 3002682307-2024-00054
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903006373
• UDI-Public: (01)00382903006373
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300637
• Device Lot Number: 220523
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1