MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PASSIVE¿ NEEDLE GUARD; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 47594130

Device Problem Break (1069)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

H.6.Investigation summary: unconfirmed: no evidence provided.

Event Description

It was reported that the bd ultrasafe passive¿ needle guard broke.The following information was provided by the initial reporter: complaint submitted on 05mar2024.Per cro: ¿subject reported a malfunction because the needle was bent and the outer cover was missing.¿ per attached complaint from site ¿syringe fell apart.¿ return of device requested 05mar2024.

• Brand Name: BD ULTRASAFE PASSIVE¿ NEEDLE GUARD
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer (Section G): BECTON DICKINSON HUNGARY KFT (BD); uveggyar utca 3; kornye tatabanya 2851 ; HU 2851
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18960606
• MDR Text Key: 338590604
• Report Number: 3009081593-2024-00011
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47594130
• Device Lot Number: 1202283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1