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 Codes	Detachment of Device or Device Component (2907); Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
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 an issue with the blue wings breaking off easily.Additional information provided by the customer on 18-aug-2020 stated that the employee was stuck with the needle.The needle was clean as it happened before he drew the patient.He washed with soap and water then applied a bandaid.No bloodwork was done on the employee.
Additional Manufacturer Narrative
Eighty representative samples were received at the manufacturing site for evaluation.All samples arrived in their original packaging with lot number 192210040.Upon a visual and functional evaluation of the samples, the reported issue could not be confirmed.The samples passed both the visual and functional evaluations with no issues detected.A root cause could not be determined as the reported issue was not confirmed.The device history record was reviewed for lot number 192210040 and indicated that the product was released accomplishing all quality standards.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• 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: 10423095
• Report Number: 1282497-2020-09356
• Device Sequence Number: 16842873
• Product Code: FOZ
• UDI-Device Identifier: 10884521013018
• UDI-Public: 10884521013018
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 12/04/2020

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: 8881225190
• Device Catalogue Number: 8881225190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 12/04/2020
• Patient Sequence Number: 1