MAUDE Adverse Event Report: C.R. BARD, INC. EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number REF# 5913230

Device Problem Fitting Problem (2183)

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

Event Date 02/09/2019

Event Type  Injury  

Event Description

Patient came in for a tunneled dialysis catheter.Bard equistream kit opened and sheath placed.When placing catheter it was found that it did not fit in the sheath.In the kit was a 15f sheath instead of a 16.5f sheath.A second kit was opened and the same problem was found.An alternative sheath was found and used.No complications from the procedure.All kits were pulled and lot# recv3572 were all found to have 15f sheaths instead of 16.5f.

• Brand Name: EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER WITH PRELOADED STYLET
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 8337045
• MDR Text Key: 136532564
• Report Number: MW5084021
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/11/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: REF# 5913230
• Device Lot Number: RECV3572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR