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

Catalog Number 393229

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that fluid "shot out" of the bd venflon¿ pro safety peripheral safety iv catheter port when it was opened.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "customer also reported that a patient was having clear fluids through another venflon pro safety cannula and when the port was opened for access, the clear fluid shot out of the port under pressure.".

Event Description

It was reported that fluid "shot out" of the bd venflon¿ pro safety peripheral safety iv catheter port when it was opened.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "customer also reported that a patient was having clear fluids through another venflon pro safety cannula and when the port was opened for access, the clear fluid shot out of the port under pressure.".

Manufacturer Narrative

H6: investigation summary: there was no sample or photo provided to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.A device history record could not be evaluated as the lot number is unknown.From the verbatim, the probable root cause for the leakage could be due to valve issue.Capa# 1379444 has been initiated to address the issue.H3 other text : see h.10.

• 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: 11096554
• MDR Text Key: 225129909
• Report Number: 8041187-2020-00884
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393229
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/05/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1