MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS CATHETER

Model Number UNKNOWN DIALYSIS

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to covidien on 6/6/2016 that a customer had an issue with a dialysis catheter.The customer reports on (b)(6) 2015, the patient found the catheter cracked.The patient went to the hospital and peritonitis was diagnosed.According to the feedback from the nurse, the patient had been to the hospital a week ago and an obvious crease could be seen.The nurse told the patient to fix the catheter well and pay more attention, but the catheter still cracked a week later.The cracked part has been cut off and replaced.

Manufacturer Narrative

Date submitted: 07/28/2016.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 record (dhr) review or product/process change review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.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, the following potential causes were identified: customer misuse, inspection in process failed or not performed, or improper materials selected.No trends or triggers have been found.No additional actions were 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 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 manuf. solutions sa; edificio 820 calle#2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: matthew amaral ; 15 hampshire st; mansfield, MA 02048 ; 2034926373
• MDR Report Key: 5702096
• MDR Text Key: 46662609
• Report Number: 3009211636-2016-00253
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN DIALYSIS
• Device Catalogue Number: UNK DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• 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): Required Intervention