MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CATHETERS SHORT TERM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Catalog Number 101512MDR

Device Problems Break (1069); Failure to Disconnect (2541)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2023

Event Type  malfunction  

Event Description

It was reported that there was a connection issue with one unit of gamcath gdk 810p during use.The operator needed to disconnect to switch lines per normal practice.However, when the line was disconnected from the vascath the ¿male end¿ of the gamcath broke off and became stuck in the vascath.Troubleshooting was performed, but the operator was unable to disconnect the male luer from the vascath and needed to replace the vascath.When they replaced the vascath, the new vascath was also very stiff to connect.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to h6 and h10.The actual device was not available; however, photographs of the sample were provided for evaluation.The returned photographs were reviewed, and it was noted that there was a crack on the male connector from the blood line.The reported condition was verified.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Corrected information: d4: catalogue #: the correct lot number is 101512 (not 101512mdr as previously reported).H10: the aware date for the mdr report number 3004367028-2023-00006: should have been (b)(6)2023 (not (b)(6)2023 as previously reported).Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CATHETERS SHORT TERM
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN CATHETER; linsenacker 1; hechingen 72379 ; GM 72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18210646
• MDR Text Key: 329030431
• Report Number: 3004367028-2023-00006
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

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: Other
• Device Catalogue Number: 101512MDR
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 12/08/2023; 12/28/2023
• Supplement Dates FDA Received: 12/28/2023; 01/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: VASCATH