MAUDE Adverse Event Report: COVIDIEN MANUF. SOLUTIONS SA UNKNOWN DIALYSIS; DIALYSIS CATHETER

Device Problems Corroded (1131); Hole In Material (1293); Device Disinfection Or Sterilization Issue (2909)

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

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

Submit date: 2/3/2017.An investigation is currently underway; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter.The customer states that the patient found a little hole close to the outlet tube on (b)(6) 2017.The patient informed is due to iodophor disinfection outlet tube and tube corrosion caused infection, then got peritonitis.The patient accepted antibiotic medicine treatment but forget the name of the antibiotic.Now the patient has stopped dialysis.

Manufacturer Narrative

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 record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to a 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.No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time.More information was requested from the customer and no additional evidence was provided for this analysis.Based on the limited information received, this most likely could be a pd catheter.The pd manufacturing process was reviewed.Tubing is a purchased component, accepted after an incoming sampling inspection per procedure.The catheter is assembled manually and 100% visually inspected for nicks, cuts or blemishes that do not mee t drawing specifications.In addition, this catheter is subject to sampling inspection and a sterilization cycle.The adapter used in this catheter is assembled during insertion by the physician.The evidence provided is not enough to relate this event to the manufacturing operations.Additionally, there are a number of alternatives in the field like exposure to contaminating agents, or manipulation that may cause the reported infection.The instructions for use (ifu) indicate that infection is considered as a potential late complication inherent to this medical procedure and therefore it is not necessarily related to the devices performance.In-process controls, such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.Manufacturing performs 100% visual inspection during production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

Event Description

The customer states that the patient found a little hole close to the outlet tube on (b)(6) 2017.The patient informed that it is due to iodophor disinfection outlet tube and tube corrosion caused infection, and then got peritonitis.The patient accepted antibiotic medicine treatment but forgets the name of the antibiotic.Now the patient has stopped dialysis.

• Brand Name: UNKNOWN DIALYSIS
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer (Section G): COVIDIEN MANUF. SOLUTIONS SA; edificio 820 calle#2; zona franca coyol; alajuela 20101
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6299679
• MDR Text Key: 66445100
• Report Number: 3009211636-2017-00104
• Device Sequence Number: 1
• Product Code: FKO
• 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: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR