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

Model Number 8888160333

Device Problem Air Leak (1008)

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

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: (b)(6) 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 an umbilical vessel catheter (uvc).The customer reported that after placing the catheter and drawing blood for lab work, microscopic bubbles continued to be observed just below the hub where the catheter is joined.They could not tell there was a problem until the catheter was placed in the baby, it requires resistance to be able to see the micro bubbles.Chlorhexidine was used to clean the skin area and the area was completely dried prior to insertion.It was not difficult to handle the catheter during insertion.It was not difficult to secure and was sutured to the stump of the umbilicus vein.The uvc was pulled before use.Ten ml ns was used to flush the line.The uvc was removed (b)(6) 2016 and was replaced with another umbilical catheter.The patient remains an inpatient.

Manufacturer Narrative

The manufacturing lot number associated with this complaint was provided and a device history record (dhr) review indicated that there was no quality issues associated with this reported mode.All dhrs are reviewed for accuracy prior to product release.The sample consisted of two uvc catheters; one of the samples presented signs of use (remains of blood) inside an original polybag of the catheter.Additionally, a syringe and a set of an unknown manufacturer were received with the catheters.Visual inspection confirmed that the samples belong to product id 8888160333 (assy-packaging, umbilical vessel catheter with hub).In order to confirm the issue reported a functional test was required.After testing, a hole below the strain relief in the catheter was found in the used sample and the other sample did not reveal any issues during functional testing or visual inspection.During the manufacturing process, catheters are submitted to a 100% pressure testing.The issue occurred after being in use in a patient, additionally, based on the reported dwell time; approximately 3 days without any issue.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.Clinician pinches catheter during hub changes or other normal use causing a concentrated stress point, resulting in a catheter leak or break.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 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 use that may lead to tubing tear.Moreover, the holes encountered caused a leak which would be identified during assembly operations.Based on the available information, it can be concluded that the product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time; therefore the most probable root cause can be considered as misuse; this issue was more likely damaged during use caused due to an inappropriate manipulation by the user.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 MANUFACTURING SOLUTIONS SA; edificio 820 calle #2 zona france coyol; edificio 820 calle #2 zona france coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5436190
• MDR Text Key: 38774639
• Report Number: 3009211636-2016-00075
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• 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
• Device Lot Number: 1525200090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1