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

Model Number 8888160333

Device Problems Kinked (1339); Leak/Splash (1354)

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

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 states minutes after the tubing was changed the nurse noted a small leak at the hub of the uvc catheter.They mention that the uvc was kinked during the tubing change in order to prevent air from entering the line.This is a normal practice for tubing line changes.

Manufacturer Narrative

Submit date: 06/09/2016.The lot number information was not provided therefore a device history record (dhr) review could not be performed.A sample was received for analysis and investigation; it consisted in one used sample with blood residue.Functional testing was performed in order to confirm the condition reported by the customer.The test of the catheter showed a leak in the tubing.A visual inspection of the sample revealed an irregular hole in the tubing below the strain relief.The strain relief was measured in order to determine that the product was within product specifications and the result is 0.60 in.The result was compared to the tolerance 0.59 to 0.61 and to the tolerance 0.72 to 0.74.Based on this information most likely the strain relief pertains to the old design and it was manufactured at a different manufacturing site.Based on the available information, it can be concluded that 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 unintentional misuse; this condition was more likely damaged during use caused due to an improper handling 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 product specification 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 solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5474055
• MDR Text Key: 39542929
• Report Number: 3009211636-2016-00093
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• 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: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1