MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS CATHETER

Model Number UNKNOWN DIALYSIS CATHETER

Device Problem Break (1069)

Patient Problems Purulent Discharge (1812); Pain (1994)

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date:05/04/2016 an investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on 04/20/2016 that a customer had an issue with a dialysis catheter.The customer stated that on (b)(6) 2016, the extension tube was broken.The catheter was intubated in 2011.The patient experienced purulent in the abdomen and felt pain.The physician performed an extubation surgery for the patient and removed the catheter.The patient is currently fine.

Manufacturer Narrative

An investigation was performed.This complaint has not been confirmed.The actual sample involved in the reported incident was not returned for evaluations.No additional information, pictures or videos were received.Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation.As no lot number was identified, a manufacturing device history review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The complaint description states that [the customer stated that on (b)(6) 2016, the extension tube was broken.The catheter was intubated in 2011.The patient experienced purulent in the abdomen and felt pain.The physician performed an extubation surgery for the patient and removed the catheter.The patient is currently fine.] no sample or additional information was received for testing and investigation.If the sample is returned in the future, this complaint will be re-opened for further investigation.The available information was analyzed and it did not allow confirming a root cause for the event, however, to brainstorm was performed in order to identify the possible causes for the failure extension tube - leaking.The following potential causes were identified: defective material, operator failed to follow process and inspection procedures, customer misuse (over bending, excessive force, and sharp object), equipment malfunction.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 performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: DIALYSIS UNKNOWN
• 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 st.; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5630696
• MDR Text Key: 44909219
• Report Number: 3009211636-2016-00195
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/20/2016

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: UNKNOWN DIALYSIS CATHETER
• Device Catalogue Number: UNK DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• 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