MAUDE Adverse Event Report: COVIDIEN 3.5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number	8888160531
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the heparin would not flush through the line when prepping the patient.There was no patient harm.
Additional Manufacturer Narrative
H 3: evaluation summary: because the lot number was not available, a manufacturing device history record (dhr) review 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.One unused catheter was received with its original package opened.The initial test showed that ink did not pass through the secondary extension.Additional testing was performed in order to confirm the location of the occlusion.Based on this testing it was determined the occlusion is at the ¿y¿ junction of the catheter.The occlusion was created by an air pressure chamber not allowing the fluids to enter.A corrective and preventative action (capa) was opened to address this issue.The root cause and corrective or preventive actions will be addressed in this capa.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 3.5FR 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: 9787680
• Report Number: 3009211636-2020-00692
• Device Sequence Number: 1866246
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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: No Information
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1