MAUDE Adverse Event Report: COVIDIEN 3.5FR DUAL-LUMEN UVC CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160531

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/12/2016.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.The customer reports that a small hole was found in the umbilical vessel catheter.

Manufacturer Narrative

Submit date 03/02/2017.A sample was received for evaluation; it consisted in one dual lumen uvc catheter and three unknown devices that came inside a generic plastic bag and present signs of use (blood residues).A visual inspection was performed and no visual defects were visible.In order to confirm the reported condition, an underwater test was performed; the distal end of the sample was clamped and the lumens were pressurized to check for leaks.When air was infused into the lumens (primary and secondary), bubbles were detected during the test; they coming out from an irregular cut in the primary lumen, the secondary lumen, did not show bubbles during the test.Based on the available information, it can be concluded that product was manufactured according to specifications and the device functioned as intended for a period of time, the defect was not identified prior to insertion and it occurred after the customer manipulation; therefore the most probable root cause can be considered as unintentional misuse more likely damaged during use due to the handling of the product by the user.The reported complaint was not confirmed to be a manufacturing related issue, 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.

• Brand Name: 3.5FR DUAL-LUMEN UVC 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 ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6167379
• MDR Text Key: 62605896
• Report Number: 3009211636-2016-00498
• 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: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160531
• Device Catalogue Number: 8888160531
• Device Lot Number: 1614700117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1