MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. EQUISTREAM XK LT HEMODIAL CATH

Catalog Number 6913230

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Dislodged or Dislocated (2923)

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

Event Type  malfunction  

Event Description

It was reported via email to the rep that the hospital has had an equistream dialysis catheters had fallen out.It was inserted on (b)(6) and sutures were removed on (b)(6).

• Brand Name: EQUISTREAM XK LT HEMODIAL CATH
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.; salt lake city UT
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116-0000 ; 8015224969
• MDR Report Key: 4213989
• MDR Text Key: 21243539
• Report Number: 3006260740-2014-00540
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6913230
• Device Lot Number: REYC0368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention