MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383005

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/08/2022

Event Type  Injury  

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system needle broke in the patient's vein, requiring a partial incision of epidermis to remove it.The following information was provided by the initial reporter, translated from chinese: "(b)(6) 2022 at 9:42 in the morning, the nurse used an indwelling 18g needle.When the tube is placed, it is found that 1/3 of the needle was broken in the body when the needle is withdrawn.Immediately inform the doctor, take a partial incision of the epidermis, and remove the needle when the broken needle tube is found.Replace one after taking it out and notify the supplier".

Manufacturer Narrative

Initial reporter e-mail: unknown.Investigation summary: in response to the reported event a device history review was conducted for lot number 1111432.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15572655
• MDR Text Key: 301504598
• Report Number: 3014704491-2022-00475
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903019489
• UDI-Public: (01)00382903019489
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383005
• Device Lot Number: 1111432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2021
• 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
• Patient Outcome(s): Required Intervention