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

Model Number 8888160432

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/23/2021

Event Type  Injury  

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 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
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12191994
• MDR Text Key: 262412735
• Report Number: 3009211636-2021-00759
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10884527005161
• UDI-Public: 10884527005161
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/19/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other