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

Model Number 8888145252

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Tissue Damage (2104)

Event Date 10/07/2014

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 the tunneler sleeve came off while tunneling.The surgeon was not able to tunnel and had to open another product.The unit is contaminated and will not be returned for investigation.The device was applied to tissue there was very little blood loss with no vessel wall damage.The surgical time was extended to 10 minutes.The instrument broke inside the patient and surgeon used forceps to remove the tunneler sleeve from the tissue.

Manufacturer Narrative

Submit date: 11/07/2014.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 consisted of one opened and incomplete 14.5 fr mahurkar maxid kit.The components received consisted of an assembled catheter 14.5 fr x 23 cm maxid with sideholes, one dilator 12 fr, one dilator 14 fr, a marked guide wire coiled, one valved pull-apart sheath and one bendable dialysis tunneler.After a visual inspection, the bendable tunneler was bent in two sections and the sheath was missing.Dimensional testing was done and the bendable tunneler was found within specifications.Since the molded sheath was not returned, it was not possible to perform dimensional testing.The most probable root cause can be due to exposure to chemical agents or exposure to heat sources that may lead to sheath dimensional change.A corrective action is not warranted at this time.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 non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: MAXID 23/48 KIT W/SIDEHOLES
• 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; 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: 4234650
• MDR Text Key: 4972864
• Report Number: 3009211636-2014-00148
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888145252
• Device Catalogue Number: 8888145252
• Device Lot Number: 322738X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• 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: 55 YR