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

Catalog Number 112714

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.A visual inspection observed a crack running in longitudinal direction, starting from the connector borderline and running along a grip.The crack was approximately 19-20 mm length.The lateral area near the thread showed some micro cracks.The reported condition was verified.The cause could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during use with a gamcath, an external leak from the extension tube nearby a connector.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: GAMCATH
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - HECHINGEN CATHETER; linsenacker 1; ni; hechingen 72379 ; GM 72379
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 11487351
• MDR Text Key: 245324455
• Report Number: 3004367028-2021-00001
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 112714
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1