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

Model Number 8888145251

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/02/2015

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 the catheter was connected without complications.After 10 minutes of the connection, the patient reported the bandage of the catheter was wet.There was blood noticed, there was active bleeding through a small hole in the catheter.The hole was near the connection of the hemodialysis lines.There was no patient harm but the catheter had to be pulled and replaced with a new one.The sample will not be available because it was contaminated and was disposed.

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 complaint sample was not returned to the manufacturing site for review.Without the sample, it is not possible to determine a confirmed root cause for this issue.Should the sample be returned in the future, this complaint will be re-opened for further investigation.The manufacturing lot number associated with this complaint was released on 05/22/2013.Since the sample was not returned, there is not enough evidence to determine what could cause the hole near the connection of the hemodialysis lines.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.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: 4538659
• MDR Text Key: 5515813
• Report Number: 3009211636-2015-00119
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 02/17/2015

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: 312907X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR