MAUDE Adverse Event Report: COVIDIEN MAXID 19/38 KIT W/SIDEHOLES; DIALYSIS CATHETER

Model Number 8888145251

Device Problems Air Leak (1008); Crack (1135); Hole In Material (1293); Improper Flow or Infusion (2954)

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

Event Date 12/30/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter.The customer stated that the cvc was cracked underneath the bifurcate (the y).There was air coming from the arterial side of the cvc branch up to the arterial trap of the instrument.There was a little bit of blood under the cvc.Treatment was stopped and the restitution was not completed.Duration of treatment was 2 hrs instead of 4 hrs.Clamps were applied on top of the 2 cvc clamps on the branches.When we slightly bend the cvc, there is dry blood leaking under the cvc and there is a small hole.The patient was already hospitalized.The catheter was pulled on (b)(6), 2014 and replaced.No patient injury.

Manufacturer Narrative

(b)(4).An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The product sample was not returned, but four photos were provided by the costumer.A mahurkar catheter is inserted on a patient and residues of blood can be seen below the hub.In one of the images, a hole can be noticed below the hub.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.Catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, cuts, etc., which could impair its performance.The device was in use for approximately 2 years with 6 months.The device was more likely damaged during use.The most probable root cause could be due to excessive force or due to an improper use of cleaning agents.The lot involved in this event was manufactured on 05/03/11, before the implementation of actions related to a corrective and preventive action (capa).It was defined that this event is being handled through this capa and no additional actions are 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 in place to prevent non-conforming product from leaving the manufacturing operations.As per the 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 19/38 KIT W/SIDEHOLES
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela ; CS
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4526366
• MDR Text Key: 5353260
• Report Number: 3009211636-2015-00109
• 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,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2015

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: 8888145251
• Device Catalogue Number: 8888145251
• Device Lot Number: 112517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2011
• 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
• Patient Age: 73 YR