MAUDE Adverse Event Report: COVIDIEN ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that during a blood draw from an umbilical artery catheter, a leak was noted at the distal end.The line was clamped and the neonatal nurse practitioner was able to repair the line using a blunt needle until a new umbilical catheter was inserted.The customer further reports that there was no patient harm.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reported that during a blood draw from an umbilical artery catheter, a leak was noted at the distal end.The line was clamped and the neonatal nurse practitioner was able to repair the line using a blunt needle until a new umbilical catheter was inserted.The customer further reports that there was no patient harm.¿ no lot number was provided.A review of the device history report (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.One (1) incomplete uvc catheter and one (1) unknown extension were received for evaluation.Visual inspection observed signs of use (residues of blood and dirt).It was also observed the catheter was cut below the strain relief.Therefore, the underwater test to verify any leakage in the catheter was unable to be performed.Potential causes of the reported condition include defective material, operator failed to follow process or inspection procedures, user did not follow instructions, inappropriate technique or use of cleaning agents, sharp objects/instruments by the user, machine malfunction, or measurement specifications.During the manufacturing process, catheters are submitted to 100% pressure testing.Based on available information, it can be concluded the product was manufactured according to specifications.Therefore, the most probable cause for the reported issue is misuse.The reported event most likely occurred during use caused by an inappropriate manipulation by the user.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].The reported customer complaint is not confirmed.The probable root cause was determined to be misuse.A formal capa investigation is currently in progress.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7365452
• MDR Text Key: 103299653
• Report Number: 3009211636-2018-00087
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3