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

Catalog Number 391350

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Necrosis (1971)

Event Date 11/22/2018

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 2 baby's had extravasations and skin necrosis.Surgery was needed to correct the serious injury.

Event Description

It was reported that while using bd neoflon¿ iv cannula 2 baby's had extravasations and skin necrosis.Surgery was needed to correct the serious injury.

Manufacturer Narrative

Investigation summary: dhr- no qn was raised for and batch # 7354461.1 representative sample (batch #7354461) was returned for investigation.The representative sample was subjected to visual inspection, tip od measurement and bevel angle measurement.The representative sample passed the acceptance criteria.The root cause cannot be determined as the 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.

• 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: 8164811
• MDR Text Key: 130362540
• Report Number: 8041187-2018-00468
• 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: 01/10/2019

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?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 391350
• Device Lot Number: 7354461
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention