MAUDE Adverse Event Report: COVIDIEN UVC TRAY/5.0 FR PU; CATHETER, UMBILICAL ARTERY

Model Number	8888160432
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2021
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported a uvc fragment was incidentally identified in the nicu patient¿s aorta on imaging.The rn removed the catheter and noted it was not intact.The markings indicated there was 15cm missing.The uvc was inserted at another hospital.Additional information received stated, per staff interview, the standard process to remove a uvc is to clip the suture and then pull gently and slowly on the catheter for removal.The rn didn't notice anything unusual about removing the catheter following this process.The patient was transferred to an out of network facility and the retained arterial catheter was removed by the ir team.There were no identified complications caused by the retained arterial catheter.

• Brand Name: UVC TRAY/5.0 FR PU
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 12191994
• Report Number: 3009211636-2021-00759
• Device Sequence Number: 14509926
• Product Code: FOS
• UDI-Device Identifier: 10884527005161
• UDI-Public: 10884527005161
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2021

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 Expiration Date: 02/28/2023
• Device Model Number: 8888160432
• Device Catalogue Number: 8888160432
• Device Lot Number: 2102200111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other