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

Model Number 8888160333

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/9/2018.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported while changing the iv tubing on the patient¿s umbilical artery catheter, it was pinched to prevent bleed back.After connecting the new tubing, it was noticed to be leaking right at the base of the hub.Blood was backing up and leaking from the catheter.The neonatal nurse practitioner (nnp) was notified and she ordered to discontinue the line as the patient was going to cardiac surgery in the morning and would have arterial access placed then.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the customer reported while changing the iv tubing on the patient¿s umbilical artery catheter, it was pinched to prevent bleed back.After connecting the new tubing, it was noticed to be leaking right at the base of the hub.Blood was backing up and leaking from the catheter.The neonatal nurse practitioner (nnp) was notified and she ordered to discontinue the line as the patient was going to cardiac surgery in the morning and would have arterial access placed then.¿ 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 in place to prevent nonconforming product in the manufacturing process.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.Catheters are submitted to a pressure test during the production process which would identify this issue in the catheter assembly.Inspectors routinely examine the product to ensure it meets acceptable quality level (aql) sampling criteria.A lot cannot be released unless it passes all visual and physical testing requirements.Multiple components are used in the manufacture of this product.Com ponent properties are also tested by the suppliers and controls are also in place to prevent non-conforming material being utilized in the finished product.One (1) sample was returned for evaluation.The sample consisted of a used uvc catheter.The sample came inside a generic plastic bag.During visual inspection, signs of manipulation were observed on the catheter.An underwater test was performed and a leak below the strain relief was identified.Due to the appearance of the catheter received, it is possible that the catheter was damaged by instruments with sharp or rough edges during clinical use, resulting in catheter leakage.Additionally, the catheter was in use for a period of time without issues, which implies that the defect occurred after customer manipulation.It is important to consider that the instructions for use warn: 1) do not use if unit package is opened or damaged; 2) umbilical catheters should be inserted and removed only by a qualified, licensed physician or other healthcare practitioner authorized by and under the direction of such physician; 3) do not use clamps on umbilical vessel catheters; 4) ensure that all connections to the catheter are secure; 5) placement must be determined by x-ray; 6) check extremities for discoloration and blanching while the catheter is indwelling; 7) if a catheter thrombus is suspected, do not flush.Follow hospital protocol and physician orders for aspiration and declotting; 8) 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 br eak; 9) ensure gloves or other surfaces which have alcohol on them are completely dry before touching or manipulating the catheter; 10) 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: 11) do not use instruments with sharp or rough edges directly on the catheter since even a minor cut could tear or break the catheter.The reported customer complaint is confirmed.A root cause could not be determined.Based on the available information, it can be concluded that product was manufactured according to specifications.Therefore, the most probable cause is misuse.This catheter was most likely damaged during use caused by inappropriate manipulation by the user.No corrective or preventive action is planned at this time.This complaint will be used for 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: 7406385
• MDR Text Key: 104707463
• Report Number: 3009211636-2018-00113
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2018

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: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 03/20/2018
• Supplement Dates FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1