MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II IV CATHETER PRN ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383019

Device Problem Material Deformation (2976)

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

Event Date 08/29/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported, a device history review was conducted for lot number 9050858.Our records show that this is the only instance of this issue occurring in this production batch.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.

Event Description

It was reported that the bd intima ii¿ iv catheter prn adapter was damaged during the high-pressure contrast injection.The following information was provided by the initial reporter, translated from (b)(6) to english: "on (b)(6) 2021, the patient went to the radiology department for enhanced ct examination of the whole abdomen.When the nurse injected drugs, the high-pressure syringe reported an emergency error.The nurse immediately suspended infusion and checked the patient's condition.After checking, the nurse found that the indwelling needle was damaged.Contrast agent was injected with a high-pressure syringe without any other medical device combination." "it is a high frequency injection, but the specific pressure value is now uncertain.".

• Brand Name: BD INTIMA II IV CATHETER PRN ADAPTER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• MDR Report Key: 12586844
• MDR Text Key: 283595175
• Report Number: 3014704491-2021-00184
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Catalogue Number: 383019
• Device Lot Number: 1051539
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1