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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING
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BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, STER; SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number H93811
Device Problems Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 12/14/2020
Event Type  malfunction  
Manufacturer Narrative
Only one device was received for evaluation.No other samples were received and therefore, could not be evaluated.A visual inspection was done which observed the tube set tubing was received with the detached spike found loose in the opened primary packaging.Since the spike was received detached from the tube set tubing, functional testing could not be performed.The reported condition was verified.The cause was not determined; however, the most likely cause was due to inadequate adhesive being applied in the manufacturing process at the spike connection to the tubing.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.
 
Event Description
It was reported that ¿several¿ (unspecified quantity) repeater pump tube sets leaked.The customer reported that ¿the spike on the end pulls straight out of the tube when handled¿ and during this the tubing leaks.This was identified during set-up prior to patient use.There was no patient involvement.No additional information is available.
 
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Brand Name
TUBE SET, STD VOL, STER
Type of Device
SYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
AVAILMED
c. industrial lt. 001 mz. 105
no 20905 int a, col cd ind.
tijuana, baja california 22444
MX   22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11266755
MDR Text Key230023129
Report Number1416980-2021-00316
Device Sequence Number1
Product Code NEP
UDI-Device Identifier00085412475721
UDI-Public(01)00085412475721
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue NumberH93811
Device Lot Number60251708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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