MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 393226

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.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.Device manufacture date: unknown.

Event Description

It was reported that during use of the bd venflon¿ pro safety shielded iv catheter after catheter insertion thrombosis developed.The following information was provided by the initial reporter, translated from french to english: venous thrombosis after catheterization.

Manufacturer Narrative

Investigation summary: two used cannula hub (attached with luer stopcock with tubing) were returned for investigation.As the samples were contaminated, the samples were decontaminated before investigation.The two used cannula hub were subjected to visual inspection.Flash on catheter tip was observed from 1 of the used cannula hub returned.Assembly process (material).The probable root cause could be due to the tipping station.The flashes could be causing the reported condition.The manufacturing process has been reviewed.There is an automated vision inspection system that can detect and reject product not meeting the acceptance criteria.If there is flashing on catheter tip in the manufacturing process, the defective part would be rejected by the automated vision inspection system.However, as no batch code was reported, no batch history investigation can be done.Product application: as the returned samples were used samples, the flashes could have happened during production application.

Event Description

It was reported that during use of the bd venflon¿ pro safety shielded iv catheter after catheter insertion thrombosis developed.The following information was provided by the initial reporter, translated from french to english: venous thrombosis after catheterization.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9290777
• MDR Text Key: 184848272
• Report Number: 8041187-2019-00903
• 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: 12/26/2019

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 Catalogue Number: 393226
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other