MAUDE Adverse Event Report: COVIDIEN ANG WNG 23G BCS W/LUER ADPTR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	8881225307
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer stated that they are having issues with the safety device staying locked back and the winged part was too flexible and not sturdy enough.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.Two photographs were submitted for evaluation.Based on the digital image a hole/perforation is found in the tubing line near where the butterfly is assembled.A sample was not returned to the manufacturing site for evaluation therefore a visual or functional evaluation could not be completed, and a root cause could not be determined, and corrective actions could not be identified.

• Brand Name: ANG WNG 23G BCS W/LUER ADPTR
• 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: 9874318
• Report Number: 1282497-2020-08988
• Device Sequence Number: 3183173
• Product Code: FOZ
• UDI-Device Identifier: 10884521013391
• UDI-Public: 10884521013391
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881225307
• Device Catalogue Number: 8881225307
• Device Lot Number: 191440260
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/24/2020
• Supplement Report FDA Received Date: 05/06/2020
• Patient Sequence Number: 1