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 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: one photo sample was received by our quality team for evaluation.From the photo returned, it was observed that the valve has moved within the cannula hub, verifying the customer experience.A device history record could not be evaluated as the lot number is unknown.Based on the quality team's investigation, the root cause of the leakage is due to the injection valve moving within the cannula hub.A trend for the moving injection valve has been observed for this product line.A project has been started to further determine the reason for the moving injection valve in the venflon pro safety so that a fix can be made to further prevent this issue.Customer complaint trends will also continue to be evaluated on a monthly basis.Capa#(b)(4) has been initiated to address this issue.

Event Description

It was reported that the bd venflon¿ pro safety peripheral safety iv catheter experienced leakage from injection port; blood exposure / splash during use.The following information was provided by the initial reporter: "fluid was administered via the port during surgery.When injecting the fluid, something happened with the "grey valve" that is located inside/under the injection port.There was bleeding from the port.No blood exposure to healthcare workers or mucosal membrane.".

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10212975
• MDR Text Key: 198093604
• Report Number: 8041187-2020-00371
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other