MAUDE Adverse Event Report: BECTON DICKINSON BD VENFLON¿ IV CANNULA; INTRAVASCULAR CATHETER

Catalog Number 391492

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.(b(4).Investigation: our quality engineer was unable to verify the reported complaint.A device history record review found no non-conformities.The team reviewed the process controls of assembly process and packaging process.All process controls are in place.The team also checked the catheter pull force pull force of lot# 18e0841f and found within the specification limit of minimum 15n (catheter pull force).In description of complaint it is mentioned that some part of catheter got break.There are chances that due to practice issue the catheter might got damage / cut from the catheter adaptor.Due to unavailability of defective sample or photograph further investigation could not be done.The team will monitor the defect during manufacturing and if any such incidence occur related to catheter damage or broken will take actions appropriately.The defect is not confirmed.The exact root cause is not identified.

Event Description

It was reported with the use of the bd venflon¿ iv cannula there was an issue with some parts of the catheter broke and entered into vein.They are not able to trace.Nothing found in doplar test.

Manufacturer Narrative

Investigation summary: the reported complaint was unable to be verified.A device history review found no non-conformities.The team reviewed the process controls of assembly process and packaging process.All process controls are in place.The team also checked the catheter pull force pull force of lot# 18e0841f and found within the specification limit of minimum 15n (catheter pull force).In description of complaint it is mentioned that some part of catheter got break.There are chances that due to practice issue the catheter might got damage / cut from the catheter adaptor.Due to unavailability of defective sample or photograph further investigation could not be done.The team will monitor the defect during manufacturing and if any such incidence occur related to catheter damage or broken will take actions appropriately.The defect is not confirmed.Investigation conclusion: the exact root cause is not identified.

Event Description

It was reported with the use of the bd venflon¿ iv cannula there was an issue with some parts of the catheter broke and entered into vein.They are not able to trace.Nothing found in doplar test.

• Brand Name: BD VENFLON¿ IV CANNULA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7873625
• MDR Text Key: 120241893
• Report Number: 2243072-2018-01177
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 391492
• Device Lot Number: 18E0841F
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 08/23/2018
• Supplement Dates FDA Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention