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

Catalog Number 393227

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: two photos were received by our quality team for evaluation.Upon visual inspection of the photos, the valve was observed to have moved.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of the leakage is due to the moving valve.The appropriate personnel have been notified of this complaint.Bd is aware of this issue and is in the process of implementing corrective actions to improve the customer and patient experience.This event has been added to our complaint database.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: based on the photo returned, the leakage was due to valve moved issue.Capa# (b)(4) has been initiated to address the issue.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter experienced leakage.The following information was provided by the initial reporter: on first flush post insertion cannula was heard to make a popping sound then blood was seen to come out of top cannula port.

• Brand Name: BD VENFLON PRO SAFETY SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11388420
• MDR Text Key: 241950117
• Report Number: 8041187-2021-00136
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• 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: 02/08/2021

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: 06/30/2023
• Device Catalogue Number: 393227
• Device Lot Number: 0171272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• 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