MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON PRO 24GA 0.7MM OD 19MM L; INTRAVASCULAR CATHETER

Catalog Number 391380

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

Patient Problem Extravasation (1842)

Event Date 09/05/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.Fda device problem code: 2993.Fda patient problem code: 1842.

Event Description

It was reported that neoflon pro 24ga 0.7mm od 19mm l was used and infiltration and extravasation occurred.This was discovered during use.The following information was provided by the initial reporter: the physician complaint is that since they start using neoflon pro, they have more venipuncture attempts, the catheter blood chamber is not filling completely as before and it take more time for the blood visualization in the blood chamber.The main issue as they say is the instaflush, they have more infiltration and extravasation cases and in particularly with small neonates (500g).

Event Description

It was reported that neoflon pro 24ga 0.7mm od 19mm l was used and infiltration and extravasation occurred.This was discovered during use.The following information was provided by the initial reporter: the physician complaint is that since they start using neoflon pro, they have more venipuncture attempts, the catheter blood chamber is not filling completely as before and it take more time for the blood visualization in the blood chamber.The main issue as they say is the instaflush, they have more infiltration and extravasation cases and in particularly with small neonates (500g).

Manufacturer Narrative

H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history record could not be evaluated as the lot number is unknown.Based on the quality team's investigation, the root cause of this incident cannot be determined.Based on the verbatim, the neoflon pro product seem to be functioning as intended.H3 other text : see h.10.

• Brand Name: NEOFLON PRO 24GA 0.7MM OD 19MM L
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10606166
• MDR Text Key: 209197431
• Report Number: 8041187-2020-00629
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 10/21/2020

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 Catalogue Number: 391380
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/05/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/05/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other