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

Catalog Number 383083

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/28/2019

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 as the puncture process was done there was blood leakage at the catheter.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: blood leakage at catheter was noticed during puncture process.

Event Description

It was reported that during use of the bd intima-ii¿ closed iv catheter system as the puncture process was done there was blood leakage at the catheter.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: blood leakage at catheter was noticed during puncture process.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 8325607.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.Leakage testing of the device identified an abnormality in the catheter tubing; a review of the manufacturing facility was unable to identify potential causes in the manufacturing process.The damage is most likely the result of damage sustained at our supplier's facility.Our supplier has been notified of the event and we have taken steps to strengthen the in-coming inspection of the raw materials for this type of non-conformance.

• 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: 8783058
• MDR Text Key: 151009156
• Report Number: 3006948883-2019-00543
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8325607
• Date Manufacturer Received: 06/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other