MAUDE Adverse Event Report: COVIDIEN 5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160556
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since no lot number was identified, a manufacturing device history review (dhr) or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation.No probable cause was found since no sample, picture or video were received for testing, and therefore the defect is not confirmed.If the sample is returned in the future, this complaint will be re-opened for further investigation.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that the line was due to be changed.The flash rn was trying to flush the line at the max zero and the line started leaking through the umbilicus while she flushed it.Both lumens were the same.The nurse called the nnp.The nnp came to bedside and ordered x-ray.Piv was started by the rn.The patient's glucose was checked and was 38.D10w bolus was given.They started iv fluids via iv.The uvc was clamped and picc was placed to run d30/tpn/il.
Additional Manufacturer Narrative
There was no lot number identified therefore a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be completed.However, all dhrs are reviewed for accuracy prior to product release.One used sample was received inside a plastic bag for analysis.A visual inspection of the samples showed signs of use; rest of the any solution and posiflow was connected in the adapter.The catheter did not reveal any problem; therefore, functional testing was required.The returned sample was submitted to underwater testing and did not show bubbles.The event reported could not be confirmed.Based on the physical evaluation and according to the investigation, it can be concluded that this event is related with customer perception.No trends or triggers have been found.Therefore, a corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant are in place to prevent nonconforming product from leaving the manufacturing operations.

• Brand Name: 5FR DUAL-LUMEN UVC CATH
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9560342
• Report Number: 3009211636-2020-00680
• Device Sequence Number: 2283425
• Product Code: FOS
• UDI-Device Identifier: 20884527005182
• UDI-Public: 20884527005182
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 02/18/2020

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: 8888160556
• Device Catalogue Number: 8888160556
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other