MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383062

Device Problem Improper Flow or Infusion (2954)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported, a device history review was conducted for lot number 0019788.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.Based on the description of the event, tour engineers believe that the most likely cause for this event is the forcing of fluid through the device during injection.The bd intima-ii is an infusion only device and is not rated for high pressure injections.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to confirm the root cause for this event.

Event Description

It was reported that the intima-ii y 20gax1.16in prn ec slm npvc tubing expanded and thinned during the angiography after injecting contrast agent.The following information was provided by the initial reporter, translated from chinese to english: "at 8:10 on (b)(6) 2021, the patient underwent angiography to check for aneurysms.A closed indwelling needle was placed.After the contrast agent was pushed, the transparent hose of the indwelling needle was expanded and thinned.The indwelling needle was removed and observed.No temporary skin changes were observed.".

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC
• 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: 12418181
• MDR Text Key: 283271412
• Report Number: 3014704491-2021-00117
• 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: 08/23/2021

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: Other
• Device Expiration Date: 02/14/2023
• Device Catalogue Number: 383062
• Device Lot Number: 0019788
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2020
• 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