MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 16GA 1.8MM OD 45MM L; CATHETER

Catalog Number 393229

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2020

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.(b)(4).

Event Description

It was reported that venflon pro safety 16ga 1.8mm od 45mm l leaked blood.The following information was provided by the initial reporter: valve in venflon dislodged on flushing, blood lost through injection port.

Event Description

It was reported that venflon pro safety 16ga 1.8mm od 45mm l leaked blood.The following information was provided by the initial reporter: valve in venflon dislodged on flushing, blood lost through injection port.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/14/2021.H.6.Investigation: one photo and one used sample was received by our quality team for evaluation.Upon visual inspection of the sample it was observed that there the valve had moved towards the cannula hub luer side, confirming the customer experience.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause of the leakage is due to the injection valve moving within the cannula hub.Capa#1379444 has been initiated to address this issue.

• Brand Name: VENFLON PRO SAFETY 16GA 1.8MM OD 45MM L
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11074353
• MDR Text Key: 224859699
• Report Number: 8041187-2020-00872
• 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: 01/26/2021

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 Expiration Date: 01/31/2023
• Device Catalogue Number: 393229
• Device Lot Number: 0163790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 11/28/2020
• Initial Date FDA Received: 12/27/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1