MAUDE Adverse Event Report: COVIDIEN KIT 11.5FX19.5 CE MAHURKAR; DIALYSIS CATHETER

Model Number 8813793013

Device Problem Bent (1059)

Patient Problems Fever (1858); Pain (1994)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/26/2016.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 a dialysis catheter.The customer reports that the pharmacist indicated that the catheter was bent in two segments.The catheter had to be changed on (b)(6) as the patient presented a fever and pain.Diagnosis: bone-marrow transplant.Indication for use: apheresis.

Manufacturer Narrative

Submit date: 07/18/2016.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.If samples are received at a later date, this complaint will be re-opened and the investigation continued.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 performed in the plant) are in place to prevent non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: KIT 11.5FX19.5 CE MAHURKAR
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5606652
• MDR Text Key: 44385620
• Report Number: 3009211636-2016-00174
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793013
• Device Catalogue Number: 8813793013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1