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

Model Number 8888160531

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/24/2017.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reports that a double lumen 3.5 umbilical vessel catheter (uvc) line was inserted on (b)(6) 2017 at 5.5cm.On (b)(6) 2017 the rn adjusted the uvc line per order to 5cm but did not have to un-tape the bridge.The line has been documented every 3 hours as secured and no issues until (b)(6) 2017 when it was noted to be leaking.The uvc line is noted to have a cut mark at the 21.5 marking and there is no evidence of tape around that area, since the tape has been removed.The product was replaced with the same product.The customer further reports there was no injury to the patient as a result.

Manufacturer Narrative

Submission date: 08/31/2018, an investigation was performed for the reported customer complaint: ¿the customer reports that a double lumen 3.5 umbilical vessel catheter (uvc) line was inserted on (b)(6) 2017 at 5.5cm.On (b)(6) 2017 the rn adjusted the uvc line per order to 5cm but did not have to un-tape the bridge.The line has been documented every 3 hours as secured and no issues until (b)(6) 2017 when it was noted to be leaking.The uvc line is noted to have a cut mark at the 21.5 marking and there is no evidence of tape around that area, since the tape has been removed.The product was replaced with the same product.The customer further reports there was no injury to the patient as a result.¿ a review of the device history record (dhr) for lot no.1618100082 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.One (1) dual lumen uvc catheter was returned inside a generic plastic bag.Visual inspection observed signs of use and blood residue.Under water test was performed and a leak on the mark 21.5 could be identified in the body of the catheter for both lumen.The origin of the leak was difficult to observe.Magnified pictures were taken and a clean cut on the mark 21.5 was identified.It is important to consider that the instructions for use warns: 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] 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].There are a number of alternatives on the field like exposure to chemical agents, proximity to heat sources or manipulation per se, that may lead to tubing tear.Moreover, the defect found caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production.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.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 0101
• Manufacturer (Section G): COVIDIEN; edificio b20, calle #2; alajuela 0101
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6588043
• MDR Text Key: 75869051
• Report Number: 3009211636-2017-05130
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2021
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 1618100082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1