MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

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 the device started to leak while in the patient and needed to be pulled to prevent injury.

Manufacturer Narrative

A device history review (dhr) revealed no discrepancies that may have contributed to a complaint of this reported issue.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results concludes the product met specification requirements.In addition, all dhr¿s were reviewed prior to the product release to confirm all requirements were met.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 and a probable cause could not be established.If the sample is returned in the future, this complaint will be re-opened for further investigation.According to occurrence analysis performed for this complaint the probability calculated of occurrence of harm (p1 x p2) is (o-1) is equal than the probability expected of occurrence of harm (p1 x p2) is (o-1) defined in the risk analysis chart (rac) for argyle¿ umbilical vessel catheters (uvcs)¿.Therefore, a corrective or preventive action is not deemed necessary at this time and a distributed product field action assessment (dpfa) procedure dpfa was not required for this issue.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 URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 11746202
• MDR Text Key: 248182901
• Report Number: 3009211636-2021-00745
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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
• Device Operator: No Information
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2030100082
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 07/20/2021
• Patient Sequence Number: 1