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

Model Number 8888160333

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/21/2016.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 reports the umbilical vessel catheter malfunctioned while attached to a patient in the icn.The catheter leaked around the 10cm-12cm of the catheter when solution was connected.The customer further reports that chloraprep 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 secured by suture.The uvc was inserted (b)(6) in the umbilical site.The uvc was in continuous use.A 5ml syringe.5 inch needle, was used to flush the line with ns chep.The uvc was removed (b)(6) and was not replaced.The status of the patient is stable.

Manufacturer Narrative

Submit date: 12/12/2016.The device history record was reviewed and indicated that the product was release accomplishing all quality standards.The product samples were received for investigation and consisted of fourteen uvc catheters that came inside a generic plastic bag.Three of the fourteen uvc catheters were received opened.Visual inspection was performed and the opened catheters revealed blood residues inside the catheters.Underwater test was performed and a leak below the strain relief could be identified in the three catheters, however the origin of the leak could not be observed with a naked eye.Magnified pictures were taken and holes below the strain relief were observed.As part of the evaluation, the closed packages were opened to verify if the catheter presents any defect.Under water test was performed and no leaks were observed in the other eleven catheters.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for the reported amount of time.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) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

This section is being updated to reflect the true number of samples received for evaluation.The device history record was reviewed and indicated that the product was release accomplishing all quality standards.The product samples were received for investigation and consisted of twelve uvc catheters that came inside a generic plastic bag.One of the twelve uvc catheters were received opened.Visual inspection was performed and the opened catheters revealed blood residues inside the catheters.Underwater test was performed and a leak below the strain relief could be identified in the three catheters, however the origin of the leak could not be observed with a naked eye.Magnified pictures were taken and holes below the strain relief were observed.As part of the evaluation, the closed packages were opened to verify if the catheter presents any defect.Under water test was performed and no leaks were observed in the other eleven catheters.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for the reported amount of time.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) 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 st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5968682
• MDR Text Key: 55676417
• Report Number: 3009211636-2016-00405
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• 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?: Yes
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1