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

Catalog Number 393229

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/12/2019

Event Type  Injury  

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 the bd venflon¿ pro safety peripheral safety iv catheter has been found defective during use.The following has been provided by the initial reporter: during removing the g16 vps intravenous cannula, the tip that remained in the vessel was torn off.The doctor on duty was informed.The end of the venflon was secured and the vascular surgeon was consulted.A local dressing was put on above the puncture site.The catheter remaining in the vessel was removed in the operating room conditions.

Manufacturer Narrative

H.6 investigation summary: one sample was received by our quality team for evaluation.The used sample was subjected to visual inspection and was confirmed that the sample is not a venflon pro safety (vps) sample.There is a different type of protection cap and cannula hub were observed from the returned used sample.As the returned used sample does not belong to bd tuas, no further investigation was done.Therefore, the root cause cannot be determined.A dhr was not performed as the sample provided was not a bd product.Complaint will be reopened if a correct sample is returned for investigation.

Event Description

It has been reported that the bd venflon¿ pro safety peripheral safety iv catheter has been found defective during use.The following has been provided by the initial reporter: during removing the g16 vps intravenous cannula, the tip that remained in the vessel was torn off.The doctor on duty was informed.The end of the venflon was secured and the vascular surgeon was consulted.A local dressing was put on above the puncture site.The catheter remaining in the vessel was removed in the operating room conditions.

• Brand Name: BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9546763
• MDR Text Key: 188218697
• Report Number: 8041187-2019-01066
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 393229
• Device Lot Number: 8262381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention