MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEOFLON YEL 24GA IV CANNULA; INTERVASCULAR NEEDLE

Catalog Number 391350

Device Problems Difficult to Insert (1316); Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem Extravasation (1842)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 an unspecified number of neoflon yel 24ga iv cannula caused a serious injury to the patient in the form of a change in the course of treatment.The following information was provided by the initial reporter: peelback - needle does not have any visual defects, during the insertion does not want to enter the veins, causing damage, cracks veins.Catheters curl during insertion.

Event Description

It was reported that an unspecified number of neoflon yel 24ga iv cannula caused a serious injury to the patient in the form of a change in the course of treatment.The following information was provided by the initial reporter: peelback - needle does not have any visual defects, during the insertion does not want to enter the veins, causing damage, cracks veins.Catheters curl during insertion.

Manufacturer Narrative

Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully verify this incident.While we were not able to confirm the report, a trend for the peelback issue has been identified for this product line.As part of the action plan, capa#81917, improvements to the catheter material and the design of the device are in the process of being implemented.The complaint is unconfirmed as no sample is received.No qn or abnormality was observed that could have influenced the issue during dhr review.

• Brand Name: NEOFLON YEL 24GA IV CANNULA
• Type of Device: INTERVASCULAR NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8850905
• MDR Text Key: 152944911
• Report Number: 8041187-2019-00590
• 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: 08/15/2019

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: 09/30/2023
• Device Catalogue Number: 391350
• Device Lot Number: 8262011
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/01/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other