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U.S. Department of Health and Human Services

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

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ANGEL WNG 23GX3/4X12IN TUBING CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
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.
 
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Brand NameANGEL WNG 23GX3/4X12IN TUBING
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
MDR Report Key11742015
MDR Text Key248204252
Report Number1282497-2021-10129
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8881225190
Device Catalogue Number8881225190
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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