MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER DUAL LUMEN 3.5FR; CATHETER, UMBILICAL ARTERY

Model Number	8888160333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the doctor was removing the double lumen uvc when a portion of the catheter outside of the patient snapped in half without any disturbance to the catheter.They had to get an x-ray to follow up that there wasn't a remaining piece of the line in the patient.Per additional information received on august 17, 2022, the uvc was inserted on (b)(6) 2022.The area was cleaned with chloraprep and was completely dry prior to insertion.There was no difficulty handling the catheter during insertion.The uvc was secured with sutures and there was no difficulty securing it.The uvc was used for continuous feed.The catheter body broke at ~5cm and measured 4cm after they removed the broken part.Therefore, the x-ray was obtained which confirmed no pieces were retained.It was removed on (b)(6) 2022.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One decontaminated sample with an unknown lot number was received at the manufacturing site inside of a generic plastic bag for investigation.A visual inspection revealed signs of use such as blood and a broken tube.The reported condition was confirmed.A cause-and-effect diagram was used to determine the potential cause(s) for this event.Based on all available information, the most likely root cause is user error.Based on the description of the event, the breakage of the catheter occurred after three days of use when the doctor was removing the catheter from the patient, indicating that there were no issues detected when placing or flushing the device and the catheter was in good condition prior to use.The issue was replicated during the investigation on a representative sample only by use of a sharp object.Not following the instructions for use properly could contribute to damage to the catheter during use.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: UMBILICAL CATHETER DUAL LUMEN 3.5FR
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15240228
• Report Number: 3009211636-2022-00792
• Device Sequence Number: 20447258
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown