MAUDE Adverse Event Report: COVIDIEN DIALYSIS UNKNOWN; DIALYSIS CATHETER

Model Number UNK DY

Device Problem Contamination (1120)

Patient Problems Staphylococcus Aureus (2058); Peritonitis (2252)

Event Date 06/03/2016

Event Type  Injury  

Manufacturer Narrative

Submit date: 06/22/2016 an investigation is currently underway; upon completion the results will be forwarded.

Event Description

It was reported to covidien on 06/15/2016 that a customer had an issue with a dialysis catheter.The customer states in (b)(6) 2016, the patient felt pruritus and scratch his abdomen.Then the patient developed peritonitis and was hospitalized on (b)(6) 2016.Result of culture of the effluent showed staphylococcus haemolyticus positive.The patient was given treatment of teicoplanin infusion.During in hospital, the patient did several peritoneal dialysis for effluent testing.And pd therapy was stopped and the patient transferred to hd.The patient was discharged from hospital on (b)(6) 2016.The catheter was remained in the abdomen.On (b)(6) 2016, the patient hospitalized again for peritonitis.Result of culture of the effluent was also staphylococcus haemolyticus positive.The patient was drawn the catheter on (b)(6) 2016, and was given treatment of teicoplanin infusion, 1 time every 3 days.Now the patient was recovering and was still in hospital.

Manufacturer Narrative

Submit date: 08/02/2016.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: 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, or improper aseptic techniques used during handling.No trends or triggers have been found.No additional actions were required.More information was requested to the customer and no additional evidence was provided for this analysis.This complaint will be reopened and updated accordingly if the product sample is returned or if additional information becomes available.A 100% visual inspection for nicks, cuts or blemishes that do not meet drawing specifications take place at the finale stage of production as per manufacturing procedure.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: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5742759
• MDR Text Key: 47976324
• Report Number: 3009211636-2016-00271
• 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: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK DY
• Device Catalogue Number: UNK DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• 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
• Patient Age: 55 YR