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

Model Number 8888160531

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

The customer reported that the heparin would not flush through the line when prepping the patient.There was no patient harm.

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
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9787680
• MDR Text Key: 193685042
• Report Number: 3009211636-2020-00692
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2020
• Patient Sequence Number: 1