MAUDE Adverse Event Report: COVIDIEN 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/07/2019

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 reports the umbilical catheter was leaking at the umbilical stump.The catheter was removed and replaced.

Manufacturer Narrative

A device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.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.One used uvc catheter was returned to the plant for investigation.The sample was returned in a generic plastic bag and showed signs of use (residues of blood).The sample had a syringe attached.A visual inspection and under water test were performed on the sample and the reported condition was confirmed, a leak was identified below the strain relief.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 in place to prevent nonconforming product from leaving the manufacturing operations.Based on the available information, it can be concluded that the product was manufactured according to specifications; therefore, the most probable root cause can be considered as misuse; this defect was most likely damaged during use, caused by inappropriate manipulation by the user.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

Manufacturer Narrative

A review of the device history record (dhr) for lot number 1812300097 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.100% of the catheters are submitted to a pressure test which would identify this issue in the catheter.The actual device was not returned for evaluation.Without the device or a representative sample being provided, a more comprehensive investigation could not be performed.The reported issue could not be replicated.However, two (2) digital images (photographs) were provided for evaluation.Visual evaluation of the photos was performed.The first photo shows a pouch with the batch and the expiration date.The second photo shows the reference number and catheter information.It is not possible determine the reported condition with the evidence provided.Potential causes of the reported condition could include defective material, operator failed to follow process or inspection procedures, user did not follow instructions, machine malfunction, or measurement specifications.Information is insufficient to determine whether any of these scenarios occurred.A probable cause could not be identified.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: 5.0FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8339494
• MDR Text Key: 136152200
• Report Number: 3009211636-2019-00642
• Device Sequence Number: 1
• Product Code: FOS
• 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,Followup
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 1812300097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 02/07/2019
• Patient Sequence Number: 1