MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160333

Device Problems Fluid/Blood Leak (1250); Split (2537)

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

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/11/2016.An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a single lumen umbilical vessel catheter (uvc).The customer stated that the uvc split just below the molded strain relief on the extension and allowed fluid to leak out and blood to leak backward back into catheter.The uvc was removed (b)(6) 2016 and was replaced with the same device.

Manufacturer Narrative

Because the lot number information was not provided, a device history record (dhr) review could not be performed.The product sample was received for analysis and investigation; it consisted of one used sample of a uvc catheter, product id (b)(4).Visual evaluation does not reveal visible defects; therefore functional testing was performed in order to confirm the reported incident by the customer.After the testing of the catheter, it revealed a leak in the tubing; the leak was from an irregular cut in the tubing below the strain relief.All dhrs are reviewed for accuracy prior to product release.In addition, during the manufacturing process, catheters are submitted to a 100% pressure testing.Due to the appearance of the catheter received it is possible that the catheter body was damaged by instruments with sharp or rough edges during clinical use, resulting in a catheter leakage or breakage.It is important to consider that the instructions for use warnings.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 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 that may lead to a tubing tear.The issue found caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production.Based on the available information, it can be concluded that the product was manufactured according to specification and the device functioned as intended for an undetermined amount of time; therefore the most probable root cause can be considered damage caused during use due to inappropriate manipulation.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling according to procedure) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5648229
• MDR Text Key: 45487709
• Report Number: 3009211636-2016-00210
• 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: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1