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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SYRINGE INLET, NON-STERILE; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION SYRINGE INLET, NON-STERILE; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938176
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2024
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter address: (b)(6).E1: initial reporter phone no: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the sterile packaging was unsealed in a syringe inlet, micro-volume with luer lock end.The event occurred during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
SYRINGE INLET, NON-STERILE
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 Key18917722
MDR Text Key337851540
Report Number1416980-2024-01154
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412475813
UDI-Public(01)00085412475813
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K002705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 03/15/2024
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 NumberH938176
Device Lot Number803546
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/15/2024
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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