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

Catalog Number 393230

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter leaked from the injection port during use.The patient experienced bleeding.The following information was provided by the initial reporter: just to make you aware of what appears to be a device failure with a cannula today, it was causing the patient to bleed uncontrollably through the injection ports one way valve.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter leaked from the injection port during use.The patient experienced bleeding.The following information was provided by the initial reporter: just to make you aware of what appears to be a device failure with a cannula today, it was causing the patient to bleed uncontrollably through the injection ports one way valve.

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation.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 verbatim, the probable root cause for the reported condition of this complaint could be due to the valve issue that was related to ethylene oxide (eto) sterilization.Capa#1379444 was initiated for venflon pro safety product sterilized using eto.

Event Description

It was reported that the bd venflon¿ pro safety shielded iv catheter leaked from the injection port during use.The patient experienced bleeding.The following information was provided by the initial reporter: just to make you aware of what appears to be a device failure with a cannula today, it was causing the patient to bleed uncontrollably through the injection ports one way valve.

• 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: 13560429
• MDR Text Key: 286344428
• Report Number: 8041187-2022-00087
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 393230
• Device Lot Number: 0144809
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2020
• 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