MAUDE Adverse Event Report: COSTA RICA MAXID 23/48 KIT W/OUT SIDEHOL; DIALYSIS CATHETER

Model Number 8888145002

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter.The customer states that at post placement blood leakage was found from the hub during dialysis treatment.The catheter was placed for a month.The catheter was pulled and replaced with a new one on (b)(6) 2014.

Manufacturer Narrative

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

Manufacturer Narrative

The product sample returned was received within a generic plastic bag and consisted of one 14.5 fr dual lumen hemodialysis catheter with evidence of use.After visual inspection, no defects were identified.During underwater test (functional test) no bubbles were detected.Both lumens, arterial and venous did not show bubbles during the test.More information was requested to the customer and no additional evidence was provided for this analysis.This defect has not been confirmed.With the available information, the most probable root cause for this kind of leak (if the device had been found defective) could be considered as misuse due to over bending or excessive force.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 in place to prevent nonconforming product from leaving the manufacturing operations.Per procedure, manufacturing performs 100% leak testing 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: MAXID 23/48 KIT W/OUT SIDEHOL
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COSTA RICA; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; edificio 820 calle #2 zona franca coyol; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: lawrence rock ; 15 hampshire street; mansfield, MA 02048 ; 5082616625
• MDR Report Key: 4220839
• MDR Text Key: 21527259
• Report Number: 3009211636-2014-00138
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145002
• Device Catalogue Number: 8888145002
• Device Lot Number: 317164X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 11/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1