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

Catalog Number 383012

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Investigation summary: in response to the event reported a device history review was conducted for lot number 0168635.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 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 pegasus is an infusion only device and is not rated for high pressure injections.Bd will continue to track and trend for this issue.

Event Description

It was reported that 3 bd intima ii¿ iv catheter prn adapters leaked.The following information was provided by the initial reporter: "on (b)(6) 2021, the patient underwent thoracic aortography in the ct room.During infusion of fluid from the closed venous indwelling needle, the white plug at the indwelling needle head retreated.After infusion of fluid, the fluid and blood drained together.".

• 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: 12701235
• MDR Text Key: 278574674
• Report Number: 3014704491-2021-00224
• 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: 10/05/2021

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: 07/08/2023
• Device Catalogue Number: 383012
• Device Lot Number: 0168635
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2020
• 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