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

Catalog Number 393237

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/15/2019

Event Type  Injury  

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 iv cannula "lost the patency" a few minutes after being inserted, and broke in the middle when attempting to remove it.A part of it remained in the patient, who had to be taken to the operating room and have the broken needle surgically removed under local anesthesia.The following information was provided by the initial reporter: "cannula inserted by nurse.In few minutes it lost the patency.When it was removed cannula broke in middle and a part remained there.Patient taken to ot and under local anesthesia removed surgically.The blood stained samples were not collected from the hospital.".

Event Description

It was reported that the bd venflon¿ pro iv cannula "lost the patency" a few minutes after being inserted, and broke in the middle when attempting to remove it.A part of it remained in the patient, who had to be taken to the operating room and have the broken needle surgically removed under local anesthesia.The following information was provided by the initial reporter: "cannula inserted by nurse.In few minutes it lost the patency.When it was removed cannula broke in middle and a part remained there.Pateint taken to ot and under local anesthesia removed surgically.The blood stained samples were not collected from the hospital.".

Manufacturer Narrative

H.6.Investigation: 3 photos were returned for investigation.The 1st and 2nd photos show the used cannula hub with catheter broken and the 3rd photo shows the top web with batch #8326625.A clean cut was observed on the catheter from the returned photos.From the broken edge, no stretched phenomenon or elongation of the catheter tubing can be observed to indicate any issue with the tubing material which could have caused the breakage.The manufacturing process has been reviewed and there are no sharp edges that could possibly come into contact with the catheter to cause the cut.There is an automated vision inspection system that can detect and reject product not meeting the lie distance requirement.If the catheter is broken in the manufacturing process, the defective part would be rejected by the automated vision inspection system as the product will not have any lie distance.It would also not be possible to use the product if catheter is broken before use.Based on the investigation and analysis, the reported nonconformance is not caused by the manufacturing process.The probable cause of the broken catheter could be due to cut by sharp object such as scissors during product removal from vein.However, user would had read and followed the instruction for use printed on the shelf box, which states ¿take extreme care not to cut catheter.Do not use scissors.¿.Therefore, the root cause cannot be established.

• Brand Name: BD VENFLON¿ PRO IV CANNULA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9255479
• MDR Text Key: 164880531
• Report Number: 8041187-2019-00868
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 393237
• Device Lot Number: 8326625
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention