MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383083

Device Problem Leak/Splash (1354)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system's indwelling needle tube ruptured during the ct scan, causing blood leakage.The following information was provided by the initial reporter, translated from (b)(6): "on (b)(6) 2021 at 15:41, due to the infusion of iodophoresis for ct-enhanced scanning, an indwelling needle was used, resulting in a rupture of the indwelling needle tube (about 0.5 cm from the connection port) on the same day, which affected the victim: blood leakage from the needle tube, local pain, affecting the imaging results, potential contrast agent leakage and local necrosis, on (b)(6) at 10:30, the needle was immediately withdrawn to stop the bleeding by compression, comforting the patient and family members at 10:30 on (b)(6), he immediately removed the needle to stop the bleeding, reassured the patient and family, re-punctured the tube for imaging, observed the local condition of the puncture, and applied wet compresses.The situation improved the next day.No device combination.".

Manufacturer Narrative

Investigation summary: in response to the event reported, a device history review was conducted for lot number 1203147.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, our engineers were able to determine that the most likely root 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.Bd will continue to track and trend for this issue.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13048470
• MDR Text Key: 288605803
• Report Number: 3014704491-2021-00373
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383083
• Device Lot Number: 1203147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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