MAUDE Adverse Event Report: C.R. BARD, INC (BASD) HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD K

Catalog Number 5833690

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/09/2014

Event Type  malfunction  

Event Description

It was reported that upon planned removal of catheter, cuff pulled off catheter and remained in the, left side, chest wall of the pt.The cuff was surgically removed.

Manufacturer Narrative

A photograph was submitted for review which concerned a detached cuff.The photo appeared to show the region of catheter which should have included a cuff.The indentations typically seen from a removed cuff were seen in this band.No other info could be gathered from the photograph.The complaint of a detached cuff was confirmed, but the cause is unk.A lot history review (lhr) of revk0143 showed two other similar product complaint(s) from this manufacturer.Both complaints for this lot number (revk0143) have been reported from one canada facility.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD K
• Manufacturer (Section D): C.R. BARD, INC (BASD); salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city, UT 84116 ; 8015950700
• MDR Report Key: 3831909
• MDR Text Key: 4449820
• Report Number: 3006260740-2014-00093
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5833690
• Device Lot Number: REVK0143
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/25/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/10/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• 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