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

Catalog Number 393226

Device Problems Fluid/Blood Leak (1250); Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2019

Event Type  malfunction  

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 venflon¿ pro safety shielded iv catheter blood splashed out from the front of the needle-cover.Needle cover is not protecting against blood flowing out with high pressure.

Manufacturer Narrative

Investigation: 3 representative samples were returned for investigation.The 3 representative samples were subjected to visual inspection, catheter adaptor leak test and injection valve test.The representative samples passed the acceptance criteria.No leakage was observed.A review of the past 12 months qn for catalog 393226 was performed.There is no related qn on defect or condition of leakage.The root cause cannot be determined.

Event Description

It was reported that during use of the bd venflon¿ pro safety shielded iv catheter blood splashed out from the front of the needle-cover.Needle cover is not protecting against blood flowing out with high pressure.

• 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: 8401137
• MDR Text Key: 138384018
• Report Number: 8041187-2019-00209
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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: 09/30/2021
• Device Catalogue Number: 393226
• Device Lot Number: 8261250
• Initial Date Manufacturer Received: 02/15/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 02/15/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other