MAUDE Adverse Event Report: ANGEL WNG 23GX3/4X12IN TUBING; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 8881225190

Device Problem Fail-Safe Problem (2936)

Patient Problem Rupture (2208)

Event Type  malfunction  

Manufacturer Narrative

Additional information and the incident sample has been requested but to date has not been received.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that due to the nature of the grip wings being so mobile around the needle, multiple times as they pushed the needle forward to poke into a patient¿s skin, the needle got stuck midway or did not move forward after hitting the skin as the wings moved forward up the needle instead which compromises patient care as it prevents the needle from going into the vein resulting in the need to poke another time in another spot.It also caused the vein to blow due to unintended needle movements.

Manufacturer Narrative

A device history record review could be performed since the lot number is unknown.A box of brand-new samples was received at cardinal health for evaluation.A visual and functional inspection was performed, and there were no product malfunctions found.A pull test was performed according to procedure; the specification and tolerance for cannula-wing bond strength is 3.0-lbf minimum and tube-wing bond strength is 3.0-lbf minimum.The reported condition could not be confirmed after evaluating the returned devices therefore a root cause could be determined and does not appear to be related to manufacturing/production process.This complaint will be closed with no further action and will be used for tracking and trending purposes.

Manufacturer Narrative

Additional information provided by the customer stated that no treatment was required for the blown vein besides pressure and a bandage.Based on the additional information, the health effect - impact code will be updated accordingly.H6 health effect - impact code was updated from 4648 to 4613.

• Brand Name: ANGEL WNG 23GX3/4X12IN TUBING
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 11742015
• MDR Text Key: 248204252
• Report Number: 1282497-2021-10129
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521013018
• UDI-Public: 10884521013018
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881225190
• Device Catalogue Number: 8881225190
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1