MAUDE Adverse Event Report: COVIDIEN TENCKHOFF CATH (10); DIALYSIS CATHETER

Model Number 8888423103

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Peritonitis (2252)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

Submit date: 4/22/2016.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 the patient had peritonitis and infections repeatedly after implantation.Ten days later, the patient had another surgery to remove the catheter during which the catheter fractured.The patient is stable now.

Manufacturer Narrative

Additional information was received on 6/2/2016.The catheter was originally implanted early (b)(6) 2016.The patient was diagnosed with peritonitis after intubation in (b)(6) 2016, the specific date is unknown.The physician replaced the catheter with a new one.There were no additional infections that occurred.The infection was not caused due to the catheter fracture.The fracture in the catheter occurred upon removal.

Manufacturer Narrative

Submit date: 07/20/2016.A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.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, dfmea was reviewed in order to identify the possible causes for the failure: infection.The following potential causes were identified in the dfmea or in addition to this document: improper package, package damage during handling in manufacturing, package damage during handling at the customer, improper sterile cycle, user error, leakages, foreign bodies introduction in catheter, untrained personnel attempts to reuse or during placement, improper handling techniques during placement, improper aseptic techniques used during handling.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: TENCKHOFF CATH (10)
• 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: matthew amaral ; 15 hampshire st.; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5598975
• MDR Text Key: 43360571
• Report Number: 3009211636-2016-00173
• 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,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8888423103
• Device Catalogue Number: 8888423103
• Device Lot Number: 1502100162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2016
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR