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

Catalog Number 383028

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 06/08/2019

Event Type  Injury  

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 during use of the bd intima-ii¿ closed iv catheter system, the nurse found the catheter broken with resistance in removing catheter.Hand surgery was needed to remove the remaining broken parts of the catheter.The patient had an additional wound on his hand and an additional treatment procedure.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: it was found catheter broke and discovery of resistance after withdraw, operating nurses directly press the forearm vein and tie the pulse band.Several departments in the hospital cooperated with the examination and remove the broken part of the front end of the catheter by hand surgery.The patient had an additional wound on his hand and an additional treatment procedure.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8358948.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.Although photos were submitted for evaluation, unfortunately without the ability to investigate the affected device, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

It was reported that during use of the bd intima-ii¿ closed iv catheter system the nurse found the catheter broken with resistance in removing catheter.Hand surgery was needed to remove the remaining broken parts of the catheter.The patient had an additional wound on his hand and an additional treatment procedure.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: it was found catheter broke and discovery of resistance after withdraw, operating nurses directly press the forearm vein and tie the pulse band.Several departments in the hospital cooperated with the examination and remove the broken part of the front end of the catheter by hand surgery.The patient had an additional wound on his hand and an additional treatment procedure.

• 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: 8751007
• MDR Text Key: 149765841
• Report Number: 3006948883-2019-00504
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830282
• UDI-Public: 382903830282
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2022
• Device Catalogue Number: 383028
• Device Lot Number: 8358948
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention