MAUDE Adverse Event Report: BAXTER HEALTHCARE - CLEVELAND ULTRACLAMP TUBING CLAMP; CLAMP, LINE

Catalog Number	5C4957
Medical Device Problem Codes	Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred on an unspecified date in (b)(6) 2018.The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an ultraclamp tubing clamp caused a hole on the drain tubing during use.The home patient stated that while clamping the drain line to weigh the drain bag, the fluids were leaking out where the red clamp was.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Actual device was not returned.The device was manufactured from 03/01/2018 - 03/07/2018.The actual device was not available; however, a companion of the sample was provided for evaluation.A visual inspection was performed with no issues noted.Functional testing including clamp function and device testing was performed with no issues.The reported issue was not verified.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.

• Brand Name: ULTRACLAMP TUBING CLAMP
• Common Device Name: CLAMP, LINE
• Manufacturer (Section D): BAXTER HEALTHCARE - CLEVELAND; cleveland MS
• MDR Report Key: 7652779
• Report Number: 1416980-2018-03971
• Device Sequence Number: 124084
• Product Code: FKK
• UDI-Device Identifier: 00085412070643
• UDI-Public: (01)00085412070643
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2018

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 5C4957
• Device Lot Number: GD904854
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/08/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1