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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H93811
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 04/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a cut was found on a sterile repeater pump tube set.This was identified during mixing.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h4 and h6.H4: the lot was manufactured from january 28, 2019 - january 29, 2019.H10: 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.
 
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Brand Name
TUBE SET, STD VOL, STER
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10133712
MDR Text Key194512251
Report Number1416980-2020-03223
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412475721
UDI-Public(01)00085412475721
Combination Product (y/n)N
PMA/PMN Number
K900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2021
Device Catalogue NumberH93811
Device Lot Number60168634
Was Device Available for Evaluation? No
Date Manufacturer Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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