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

Catalog Number 393230

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 09/17/2019

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 blood.This was discovered during use.The following information was provided by the initial reporter: at the end of a long case in a neuro theatre the anaesthetist went to flush the orange 14g cannula situated in the patients foot.When he took the flush out of the port site he noticed blood coming out.He put his thumb over the port site to stop the bleeding and took it off again to confirm that blood was coming out of the port site.The cannula was removed, put into a sample pot and the packaging was retrieved in order to send back to the manufactures.

Event Description

It was reported that bd venflon¿ pro safety shielded iv catheter leaked blood.This was discovered during use.The following information was provided by the initial reporter: at the end of a long case in a neuro theatre the anaesthetist went to flush the orange 14g cannula situated in the patients foot.When he took the flush out of the port site he noticed blood coming out.He put his thumb over the port site to stop the bleeding and took it off again to confirm that blood was coming out of the port site.The cannula was removed, put into a sample pot and the packaging was retrieved in order to send back to the manufactures.

Manufacturer Narrative

Correction: this complaint will be cancelled.This is a duplicate complaint of pr# (b)(4), mfr report # 8041187-2019-00788 that has already been reported for malfunction.

• Brand Name: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9161559
• MDR Text Key: 166539990
• Report Number: 8041187-2019-00789
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 393230
• Device Lot Number: 9172602
• Date Manufacturer Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other