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

Catalog Number 383078

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii¿ closed iv catheter system leaked at the adaptor.The following information was provided by the initial reporter: nurse feedback blood leakage at adaptor, asked for quality testing.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8198207.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 a sample could not be obtained for our investigation, according to previous investigations, through a variance in the autoline's swage pressure it is possible for the machine to apply excess force to the device during assembly, allowing for the resulting crack to form in the device.Currently, we are conducting a long term study to determine the root cause for this event, but we are addressing the issue through the implementation of manual inspection s for cracks in the adapter head, and we are furthur optimizing our swaging process by reducing depth requirements.Capa 642738.

Event Description

It was reported that bd intima-ii¿ closed iv catheter system leaked at the adaptor.The following information was provided by the initial reporter: nurse feedback blood leakage at adaptor, asked for quality testing.

• 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: 8632580
• MDR Text Key: 145922285
• Report Number: 3006948883-2019-00395
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830787
• UDI-Public: 382903830787
• 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: 06/17/2019

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: 08/22/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8198207
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/07/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other