MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L; IV CATHETER

Catalog Number 393224

Device Problems Break (1069); Entrapment of Device (1212); Fluid/Blood Leak (1250); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/06/2019

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 venflon pro safety 20ga 1.1mm od 32mm l experienced cannula breakage during use.The following information was provided by the customer: patient had to get a venflon for a cag.A pink venflon was used when pricking and the pricking was done as usually.When the venflon was injected with nacl 0.9%, some liquid leaked at the insertion opening.This was wiped off and the fixation patch was replaced.Then injected again nacl 0.9% and again the same problem.Due to this it was decided to remove the venflon and make a new attempt.At the removal of the venflon a resistance was felt.Another colleague was called and felt the same resistance.The venflon then removed and then it appeared that it was broken off.It is now expected that the part that has been broken off will remain behind in the vessel.

Manufacturer Narrative

Investigation: 1 used cannula hub attached with luer connector and 1 representative sample were received for investigation.As the luer connector does not belong to bd tuas, no further investigation was done.The representative sample was subjected to visual inspection, catheter adaptor leak test and injection valve test.No leakage was observed.Actual sample leakage: the complaint is unconfirmed as no leakage test could be perform on the returned sample.Representative sample leakage: the complaint is unconfirmed as the product is within specification.A review of 12 months qn on reported nonconformance was performed.No related qn was raised.Therefore the root cause cannot be established.

Event Description

It was reported that the venflon pro safety 20ga 1.1mm od 32mm l experienced cannula breakage during use.The following information was provided by the customer: patient had to get a venflon for a cag.A pink venflon was used when pricking and the pricking was done as usually.When the venflon was injected with nacl 0.9%, some liquid leaked at the insertion opening.This was wiped off and the fixation patch was replaced.Then injected again nacl 0.9% and again the same problem.Due to this it was decided to remove the venflon and make a new attempt.At the removal of the venflon a resistance was felt.Another colleague was called and felt the same resistance.The venflon then removed and then it appeared that it was broken off.It is now expected that the part that has been broken off will remain behind in the vessel.

• Brand Name: VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8457310
• MDR Text Key: 140149032
• Report Number: 8041187-2019-00257
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 393224
• Device Lot Number: 8299894
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other