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

Model Number 8888160531

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that when administering the heparin through the line, it would not flush when prepping the patient.

Manufacturer Narrative

A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of the reported issue.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhr are reviewed for accuracy prior to product release.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements for release.One unused catheter from lot number 1905700096 was received inside of a plastic bag with its original package opened.In order to confirm the condition reported, red ink was used to flush the sample and the test showed that the ink did not pass through the extensions.Additional testing was performed in order to confirm the location of the occlusion; the extensions were cut and using a pin gage of 0.008¿ in both extensions the pin gage passed without any problem; then, the catheter was cut below the junction and the pin gage would not pass through the y junction.Based on this test is was determined that the occlusion is located at the ¿y¿ junction.The occlusion was created by an air pressure chamber not allowing the fluids to enter.The reported condition was confirmed.The observed rate of occurrence and the observed severity of harm are lower than to that which is expected.Therefore, a formal corrective/preventative action (capa) was opened to address this issue and corrective or preventive actions will be taken within this capa.Additionally, no trends or triggers have been found.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.

• 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: 9775881
• MDR Text Key: 193684664
• Report Number: 3009211636-2020-00690
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• 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
• Device Lot Number: 1905700096
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2020
• Patient Sequence Number: 1