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 05/19/2021

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

Customer reports: the device was leaking at the junction between the hub and tubing during use on a patient.The device began leaking approximately 20 minutes into use.

Manufacturer Narrative

Additional information: h4 device manufacture date; h6 health effect - clinical code; h6 type of investigation.Investigation summary: a device history record (dhr) review of the lot number revealed no discrepancies that may have contributed to the reported condition.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 dhrs were reviewed prior to the product release to confirm all requirements were met.The physical sample involved was not returned for evaluation; however, one photo was provided for review.According to the photo, a catheter with a syringe was observed and indicates where the leak could have been.A leak is not able to be identified in the photo provided.Therefore, the reported issue was not confirmed.Based on the investigation, an exact root cause could not be determined.However, as part of continuous improvements, a corrective action was opened.Actions are designed to prevent the reoccurrence of the reported condition.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.

Manufacturer Narrative

Additional information: h2, h3, h6.Investigation conclusion: the reported complaint stated that the device was leaking at the junction between the hub and tubing during use on a patient.The device began leaking approximately 20 minutes into use.The device history record (dhr) was reviewed, and no discrepancies that may have contributed to the reported condition.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 dhrs were reviewed prior to the product release to confirm all requirements were met.A total of six (6) unused products were returned for evaluation.Visual inspection showed no signs of use.Functional evaluation performed via leak test and all six samples passed.The returned products functioned as intended with no fault found; therefore, the reported product failure was not confirmed.It can be concluded that this complaint could be related with a customer perception since the defect reported was not confirmed per sample evaluation analysis.According to the information above, customer perception cause is determined as the most probable root cause.Additionally, based on the investigation performed there are controls in place to detect this type of failure mode such as leak test and 100% occlusion tests.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.Additional action will not be taken at this time.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
• Manufacturer (Section G): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11855578
• MDR Text Key: 255068888
• Report Number: 3009211636-2021-00747
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1829700083
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1