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

Catalog Number 391350

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Extravasation (1842); Necrosis (1971)

Event Date 11/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 while using bd neoflon¿ iv cannula there were 2 extravasations in baby's.There was skin necrosis and the babies needed surgery.

Manufacturer Narrative

Investigation summary: a review of the device history record revealed no irregularities during the manufacture of the reported lot.1 representative sample (batch #8052239) was returned for investigation.The 1 representative sample was subjected to visual inspection, tip od measurement and bevel angle measurement.The 1 representative sample passed the acceptance criteria.The root cause cannot be determined as the 1 representative sample passed the acceptance criteria.Based on the investigation of previous similar complaint, the probable root cause could be due to the tubing material.Capa #81917 was issued to review the tubing material.

Event Description

It was reported that while using bd neoflon¿ iv cannula there were 2 extravasations in baby's.There was skin necrosis and the babies needed surgery.

• Brand Name: BD NEOFLON IV CANNULA
• Type of Device: BD NEOFLON¿ IV CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8189940
• MDR Text Key: 131170619
• Report Number: 8041187-2018-00480
• 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: 01/11/2019

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: 02/28/2023
• Device Catalogue Number: 391350
• Device Lot Number: 8052239
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other