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

Catalog Number 391350

Device Problem Break (1069)

Patient Problem Tissue Damage (2104)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8020479.Medical device expiration date: 2023-01-31.Device manufacture date: 2018-03-08.Medical device lot #: 8109402.Medical device expiration date: 2023-04-30.Device manufacture date: 2018-04-19.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd neoflon¿ iv cannula the tip of the cannula was damaged.The following information was provided by the initial reporter: during insertion of the cannula the tip of the cannula has been damaged and when pulling back the small piece of material damaged the vein, too.

Manufacturer Narrative

Investigation: 1 photo, 1 used sample and 9 representative samples (batch #8020479) were returned for investigation.The returned photo shows the peelback on catheter tip.The used sample was subjected to visual inspection.Peelback was observed on the used sample.The 9 representative samples were subjected to visual inspection, tip od measurement and bevel angle measurement.The 9 representative samples passed the acceptance criteria.No abnormality was observed.Able to confirm the customer experience based on the returned photo and returned used sample.Unable to confirm the customer experience based on the representative samples returned.The probable root cause for peelback could be due to tubing material.Capa#81917 was issued to review the tubing material.As part of the action plan, changes to the catheter material and method of shaping the catheter tip are in the process of being implemented.A device history record review found no non-conformances associated with this issue during production of these batches.A trend for the peelback issue has been identified for this product line.

Event Description

It was reported that during use of the bd neoflon¿ iv cannula the tip of the cannula was damaged.The following information was provided by the initial reporter: during insertion of the cannula the tip of the cannula has been damaged and when pulling back the small piece of material damaged the vein, too.

• Brand Name: BD NEOFLON¿ IV CANNULA
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9218098
• MDR Text Key: 170299856
• Report Number: 8041187-2019-00840
• 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: 11/06/2019

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: Health Professional
• Device Catalogue Number: 391350
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 10/08/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other