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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400; SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION VALVE SET, EM2400; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938724
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/16/2023
Event Type  malfunction  
Event Description
It was reported that a em2400 valve set had viscous liquid in the package.This issue was identified before use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H4: the device was manufactured from november 03, 2022 - november 04, 2022.The actual device was not available; however, two (2) photographs of the sample were provided for evaluation.The photographs were visually inspected.The first photo shows a valve set in its packaging (pouch) and shows an oily residue/droplets on the inside of the pouch which appears to be on the device.The second photo is of the pouch with the valve set removed and the inside of the packaging has a clear substance, which is likely excess silicone oil on the inside of the pouch that possibly transferred from valve body to the inside of the packaging.The reported condition was verified.The cause of the condition was excess silicone used during the manufacturing assembly process, which was on the device and the inside of the pouch.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.
 
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Brand Name
VALVE SET, EM2400
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 Key17164200
MDR Text Key317677736
Report Number1416980-2023-03030
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477183
UDI-Public(01)00085412477183
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K002705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/25/2023
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
Device Operator Other
Device Catalogue NumberH938724
Device Lot Number60409272
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/26/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received07/18/2023
Supplement Dates FDA Received07/25/2023
Was Device Evaluated by Manufacturer? No
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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