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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/03/2020
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 that the patient was having labs drawn.After the tourniquet was taken off the patient¿s arm and a cotton ball placed over the needle to remove, the needle dislodged from base and was left in their arm.The needle had to be pulled out without the safety being attached.Additional information provided by the customer stated that the needle detached cleanly from the hub.The needle was in the patient's arm for one minute.The needle was removed by the clinician using their hand/fingers with gloves on.There were no injuries to the patient and no further intervention was required.

• 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: 10422587
• Report Number: 1282497-2020-09355
• Device Sequence Number: 14151899
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: 08/06/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1