MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383069

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/30/2019

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 has been reported that one bd intima-ii¿ closed iv catheter system has been found experiencing leakage during use.The following has been provided by the initial reporter: after the puncture was successful, the nurse found a large amount of blood leakage at the extension tube and the connection seat.Check the back end and find that it is loose and drop directly.The nurse urgently pulls the needle and changes the needle.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 7356283.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.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, capa#599768 to determine the root cause for this event, but we are further optimizing our swaging process by reducing depth requirements.

Event Description

It has been reported that one bd intima-ii¿ closed iv catheter system has been found experiencing leakage during use.The following has been provided by the initial reporter: after the puncture was successful, the nurse found a large amount of blood leakage at the extension tube and the connection seat.Check the back end and find that it is loose and drop directly.The nurse urgently pulls the needle and changes the needle.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9083087
• MDR Text Key: 178961646
• Report Number: 3006948883-2019-00777
• 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: 10/11/2019

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: 01/18/2021
• Device Catalogue Number: 383069
• Device Lot Number: 7356283
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 09/03/2019
• Supplement Dates FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other