MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II 20GAX1.16IN PRN SLM CATHETER

Catalog Number 383007

Device Problem Leak/Splash (1354)

Patient Problem Inflammation (1932)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 8141307. 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. Unfortunately a sample could not be obtained for evaluation and testing. Investigation conclusion: bd will continue to monitor this issue. Root cause description: 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 intima-ii 20gax1. 16in prn slm leaked during use. The following information was provided by the initial reporter: on january 20th, due to acute cholecystitis, the patient was given intravenous infusion with intravenous indwelling needle, and fluid leakage was found.

• Brand Name: INTIMA-II 20GAX1.16IN PRN SLM
• Type of Device: 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9812441
• MDR Text Key: 188673008
• Report Number: 3006948883-2020-00079
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/28/2021
• Device Catalogue Number: 383007
• Device Lot Number: 8141307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/10/2020 Patient Sequence Number: 1