MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN CATHETER GAMCATH; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number 103356

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event occulted on n unknown date in (b)(6) 2019.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that while using a gamcath gdhk-1315j during the insertion procedure the vessel dilator (reported as blue shirt) was removed with difficulties and with ¿pulling¿.¿when the guide was removed, it was torn¿, and the catheter did not give any flow.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B5: the correct product name was gamcath gdhk-1320.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: GAMCATH
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN CATHETER; deerfield IL
• MDR Report Key: 9526264
• MDR Text Key: 198551388
• Report Number: 3004367028-2019-00010
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 07332414039189
• UDI-Public: (01)07332414039189
• Combination Product (y/n): N
• PMA/PMN Number: K100451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 103356
• Device Lot Number: 2019041326
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/23/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR