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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INLET, MICROVOL,VENTED SPIKE,; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION INLET, MICROVOL,VENTED SPIKE,; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938751
Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address:(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was a disconnection between the tubing and spike of a micro-volume inlet (w/large bore spike) which resulted in a leak.The issue was identified during compounding.There was no patient involvement.No additional information is available.
 
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Brand Name
INLET, MICROVOL,VENTED SPIKE,
Type of Device
SET, I.V. FLUID TRANSFER
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 Key16214662
MDR Text Key308532067
Report Number1416980-2023-00084
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477299
UDI-Public(01)00085412477299
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K903159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberH938751
Device Lot Number60325014
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2023
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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