MAUDE Adverse Event Report: COVIDIEN PERITONEAL CATHETER KIT 62CM; DIALYSIS CATHETER

Model Number 8817278006

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Date 03/30/2015

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue while using a dialysis catheter.The customer reports that the nurse on the pd ward noticed the patient had a full body allergic reaction.This reaction occurred approximately two weeks after the catheter was inserted.The catheter has not been removed yet, the doctor is not sure if the reaction is related to the catheter.The customer states the reaction was generalized itchiness and an un-raised red rash.There was a severe reaction.The customer reported initially trialing benadryl, atarax, and betamethasone cream but ineffective.The patient is now on prednisone 40 mg po.There has been no change in diet or new medications which may have contributed.The patient is improving with prednisone.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.However, the following potential failures were identified: failed inspections or verifications per procedure, incorrect or damaged mold used during tube extrusion (causing stress at exit site due to improper bend), error in catheter placement, excessive force when inserting the catheter (not following instructions for use).With the available information it is not possible to determine a true root cause for this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.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 nonconforming product from leaving the manufacturing operations.As per (b)(4), manufacturing performs 100% visual inspection at the final stage of production, which would identify this issue in the catheter assembly.This complaint will be used for tracking and trending purposes.

• Brand Name: PERITONEAL CATHETER KIT 62CM
• 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; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4685819
• MDR Text Key: 5690907
• Report Number: 3009211636-2015-00194
• 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: Foreign,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8817278006
• Device Catalogue Number: 8817278006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2015
• 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: 72 YR
• Patient Weight: 80