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

Model Number 8888160333

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way.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 catheter (uvc).Customer reports: i have a report of a uvc line noted to be leaking at the hub while parenteral nutrition infusion in progress.Line inserted (b)(6) 2016, used for nns, nnr, preterm lipid solution, dext/h2o 10% solutions.Skin prep for insertion 0.1% chlorhexidine.Line removed (b)(6) 2016 immediately when the leak was noted.No tension was noted on the line while in use.Catheter was removed from umbilical vein immediately and alternate iv access secured.Additional information was requested on 11-29-16 and 12-1-16 with no response.

Manufacturer Narrative

A sample was received at plant for evaluation; it consisted in 1 uvc catheter that came inside a generic plastic bag.A visual inspection was performed and signs of use (blood residues) and manipulation were found.The catheter did not reveal a visible defect.An under- water test was performed and a leak below the strain relief could be identified in the catheter, the origin of the leak could not be observed with a naked eye, therefore magnified pictures were taken and hole below the strain relief was observed.The strain relief was measured in order to determine the design employed during manufacturing operations and it was confirmed that the strain relief pertains to the new design.Based on the visual evaluation it was observed that the catheter returned presents a hole below the strain relief.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 a catheter leakage.Additionally the catheter was in continuous use for a period of time without issues, which implies that the condition occurred after customer manipulation.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 condition found caused a leak which would be identified during assembly operations, since manufacturing performs 100% pressure testing during production.Based on the available information this potential cause could not be discarded.There are no complaint triggers or trends were identified, therefore no corrective or preventive actions are required.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 are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: UMBILICAL 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 st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6141079
• MDR Text Key: 61604168
• Report Number: 3009211636-2016-00482
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

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
• Device Lot Number: 153570106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: 11/14/2016
• Supplement Dates FDA Received: 11/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1