MAUDE Adverse Event Report: COVIDIEN UNKNOWN DIALYSIS CATHETER

Model Number UNKNOWN DY

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 06/18/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer reports that while flushing the dialysis catheter, a hole was discovered.The catheter was inserted (b)(6) 2015.The location of the hole is such that repair is not possible.

Manufacturer Narrative

Submit date: (b)(6) 2016.A device history record review could not be performed because the lot number provided is invalid.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 action is not required at this time.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations.As per procedure, manufacturing performs 100% visual inspection during production, which would identify nicks or cuts in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN DIALYSIS CATHETER
• 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: 5060462
• MDR Text Key: 25791627
• Report Number: 3009211636-2015-00358
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/21/2015

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 DY
• Device Catalogue Number: UNKNOWN DY
• Device Lot Number: 15526598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/21/2015
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• 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