MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383033

Device Problem Leak/Splash (1354)

Patient Problem Bronchitis (1752)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd intima-ii¿ closed iv catheter system there was an issue with leakage.The following information was provided by the initial reporter, translated from (b)(6) to english: the patient was admitted to hospital for treatment of infusion and anti-infection due to chronic bronchitis.When the nurse was administering the infusion, she found that the liquid had entered the needle joint and was leaking, and immediately replaced the needle.

Event Description

It was reported that during use of the bd intima-ii¿ closed iv catheter system there was an issue with leakage.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to hospital for treatment of infusion and anti-infection due to chronic bronchitis.When the nurse was administering the infusion, she found that the liquid had entered the needle joint and was leaking, and immediately replaced the needle¿.

Manufacturer Narrative

H.6.Investigation summary bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to leakage as all retention samples met specifications.A device history review was conducted for lot number 9050923.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.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9526115
• MDR Text Key: 179936606
• Report Number: 3006948883-2019-01128
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2022
• Device Catalogue Number: 383033
• Device Lot Number: 9050923
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other