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

Model Number 8888160341

Device Problem Break (1069)

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

Event Date 01/11/2019

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 reported there was a hole present in the umbilical catheter.The line was in for a few hours so the customer does not believe it to be related to nurses crimping the line.There was no harm to the patient.

Manufacturer Narrative

No lot number was provided.A review of the device history record (dhr) was unable to be performed.However, 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.However, manufacturing performs 100% leak testing, which would identify this issue in the catheter assembly.One (1) used uvc catheter, which came inside a generic plastic bag, was returned for evaluation.The catheter shows signs of use (residues of blood).Visual inspection and functional testing were performed.Under water test identified a leak below the strain relief in the catheter.The event reported was confirmed.It is important to consider that the instructions for use warn: [exercise caution when using sharp instruments near the catheter.Do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter.Do not pinch or bend the catheter back to temporarily occlude the catheter.This causes increased stress on the catheter which can lead to a leak or break.Do not use clamps on umbilical vessel catheters] and continues, [do not use alcohol, acetone, or alcohol containing antiseptics directly on the catheter.Carefully check antiseptic solutions for alcohol or acetone.These substances may cause irreversible damage to the polyurethane which can lead to a leak or break.Ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter].In addition the ifu states [the catheter lumen or catheter shaft should be flushed and filled with heparinized saline per hospital protocol.The catheter may be grasped with a smooth forceps or fingertips and inserted into the lumen of the dilated vessel.Catheter lumen should be occluded with saline via intermittent infusion caps or luer-lock syringes during insertion to avoid air emboli].Examination of potential causes of this issue included: misuse, nonconforming material, operator failed to follow process or inspection procedures, machine, method, or measurement.Based on the available information, it can be concluded that product was manufactured according to specifications.The device functioned as intended for a period of time.The issue was not identified prior to insertion and it occurred after customer manipulation.Therefore, the most probable cause for the reported issue is misuse.This catheter was most likely damaged during use caused by inappropriate manipulation by the user.The reported customer complaint is confirmed.The probable root cause is customer misuse.No corrective or preventive action is planned at this time.This complaint will be used for 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: 8254784
• MDR Text Key: 133327104
• Report Number: 3009211636-2019-00635
• 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
• Report Date: 03/22/2019

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: 8888160341
• Device Catalogue Number: 8888160341
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 03/22/2019
• Patient Sequence Number: 1