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

Catalog Number 383080

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that leakage occurred during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, "it was found blood leakage at tubing and y-connector.".

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 8043062.Our records have detected a trend for this issue occurring in this batch of bd intima-ii.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.Additionally, a review of the provided sample and the manufacturing process determined that the root cause is an obstruction of the swaging station¿s guiding camera during production.Although this is a rare occurrence, it is possible for the extension tubing to fall off the production line in a way that allows it to settle into a position that obstructs the guiding eye of the automated swaging station, causing the swaging process to terminate prior to completion.The plant has optimized the camera system to prevent the reoccurrence of this event.Capa 599768.H3 other text : see section h.10.

Event Description

It was reported that leakage occurred during use with a bd intima-ii¿ closed iv catheter system.The following information was provided by the initial reporter, "it was found blood leakage at tubing and y-connector.".

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8724473
• MDR Text Key: 149216194
• Report Number: 3006948883-2019-00486
• 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: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/25/2021
• Device Catalogue Number: 383080
• Device Lot Number: 8043062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Date Manufacturer Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other