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

Model Number	8881225190
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the safety lock mechanism on the 23 gauge butterfly needles do not lock securely and are made of a very thin piece of foil.The health care provider (hcp) drew a patient with a 23g syringe needle.As they were taking it out, there was a drop of blood at the end of the needle.The hcp took the needle and moved it to the gauze to take off the blood drop and went too close to their finger and stuck their left index finger.The hcp disposed of all supplies, took off their gloves and washed their hands.They were bleeding so went to the lab immediately and called their supervisor.

• Brand Name: ANGEL WNG 23GX3/4X12IN TUBING
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8666918
• Report Number: 1282497-2019-08486
• Device Sequence Number: 2257706
• Product Code: FOZ
• UDI-Device Identifier: 10884521013018
• UDI-Public: 10884521013018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2019

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
• Operator of Device: No Information
• Device Model Number: 8881225190
• Device Catalogue Number: 8881225190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other