MAUDE Adverse Event Report: COVIDIEN ARGYLE CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Leak/Splash (1354)

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

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿the umbilical artery catheter (uac) was noted to be spontaneously leaking at the distal portion of the thinnest part of the catheter, prior to the hub. The leakage was noted after a fluid change. The line was not pinched or clamped at all prior to leaking. It was later found that the prior rn had bent the line back upon itself, which led to a micro crack. ¿ 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. No product/sample was provided for evaluation. No additional information, pictures or videos were received. Therefore, a comprehensive investigation was unable to be conducted. 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. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Submit date: 7/27/17. An investigation is currently under way; upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states the umbilical artery catheter (uac) was noted to be spontaneously leaking at the distal portion of the thinnest part of the catheter, prior to the hub. The leakage was noted after a fluid change. The line was not pinched or clamped at all prior to leaking. It was later found that the prior rn had bent the line back upon itself, which led to a micro crack.

• 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: 6746930
• MDR Text Key: 247387628
• Report Number: 3009211636-2017-05240
• 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

• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown