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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NON VENTED HIGH VOL.INLET,N/S; SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION NON VENTED HIGH VOL.INLET,N/S; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938173
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2023
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a non-vented high-volume inlet had particular matter at the spike port.This was observed during the set-up.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was received for evaluation.An unaided visual inspection was performed which observed a brown spot on the spike.Upon magnification a brown spot was found embedded in the spike outer wall.The reported condition was verified.The cause of the condition was determined to be related to the manufacturing process.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
NON VENTED HIGH VOL.INLET,N/S
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
PLASTICOS Y MATERIAS PRIMAS PYMPSA
3609-2 juan de la barrera
parque industrial el alamo
guadalajara, jalisco 44490
MX   44490
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key18284146
MDR Text Key329954672
Report Number1416980-2023-06387
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K002705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/10/2024
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 NumberH938173
Device Lot Number803401
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 11/13/2023
Initial Date FDA Received12/07/2023
Supplement Dates Manufacturer Received01/04/2024
Supplement Dates FDA Received01/10/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NA.
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