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

Catalog Number 393229

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/08/2022

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.

Event Description

It was reported that bd venflon¿ pro safety shielded iv catheter leaked from the injection port.The following information was provided by the initial reporter: "blood started to flow out from port of cannula during the medical delivery.".

Manufacturer Narrative

H6: investigation summary no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 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 this incident cannot be determined.H3 other text : see h10.

Event Description

It was reported that bd venflon¿ pro safety shielded iv catheter leaked from the injection port.The following information was provided by the initial reporter: "blood started to flow out from port of cannula during the medical delivery.".

• 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
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13577915
• MDR Text Key: 286539509
• Report Number: 8041187-2022-00097
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 393229
• Device Lot Number: 1113002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2021
• 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