MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA; INTERVASCULAR CATHETER

Catalog Number 391350

Device Problem Difficult to Remove (1528)

Patient Problem Perforation of Vessels (2135)

Event Date 10/31/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.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 during use of the bd neoflon¿ iv cannula peels back after piercing venous blood vessels, making it difficult to remove the needle and the placement of the peripheral infusion fails.The peripheral blood vessels were damaged to such an extent that a deep line had to be placed.Cardiorespiratory causes stress for destabilization, resulting in (temporary) need for more respiratory support or cardiac stimulation.

Manufacturer Narrative

There is no sample and no photo returned for investigation of this complaint.Complaint will be reopened if sample is returned.A review of the device history record revealed no irregularities during the manufacture of the reported lot #.Based on the investigation of similar complaint, the probable root cause could be due to the tubing material.(b)(4) was issued to review the tubing material.

Event Description

It was reported that during use of the bd neoflon iv cannula peels back after piercing venous blood vessels, making it difficult to remove the needle and the placement of the peripheral infusion fails.The peripheral blood vessels were damaged to such an extent that a deep line had to be placed.Cardiorespiratory causes stress for destabilization, resulting in (temporary) need for more respiratory support or cardiac stimulation.

• Brand Name: BD NEOFLON¿ IV CANNULA
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8090460
• MDR Text Key: 127923046
• Report Number: 8041187-2018-00423
• 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: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 391350
• Device Lot Number: 8053439
• Date Manufacturer Received: 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention