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

Model Number 8888145251

Device Problem Hole In Material (1293)

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

Event Date 02/14/2015

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 at the beginning of the treatment, upon removal of the 4% citrate closing lock, there was presence of air at the arterial branch of the cvc.A small hole was observed close to the white sheat on the arterial side only.Additional clamp used on top of the cvc clamp on the arterial side.No patient injury.Nephrologist (b)(6) 2015.Tunnelled cvc reinstalled with guidewire on (b)(6) 2105 and after patient had his hemodialysis treatment.The device will be returned for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

The device history record was reviewed indicating that product was released accomplishing all quality standard requirements.There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint.The sample was returned for evaluation.The product sample consisted of one mahurkar 14.5 fr dual lumen catheter with sideholes catheter, 19 cm implant length, 36 cm overall length.The catheter came inside a plastic bag.Visual inspection was performed and a hole was found that looked like a kind of cut on the silicone tubing of the arterial extension.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter or components if they appear damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, or cuts which could impair its performance.The event description states the catheter functioned for approximately a year.Based on the information provided, the device was damaged during that time.The most probable root cause could be due to excessive force or the use of a sharp object.No additional actions are required at this time.It must be noted that in-process controls (such as personnel training, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.There is a 100% extension visual inspection being performed per procedure 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 ; CS
• 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: 4542030
• MDR Text Key: 5514883
• Report Number: 3009211636-2015-00124
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• 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: 310152X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• 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
• Patient Age: 81 YR