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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 Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was particulate matter (pm) contamination on the tubing of a repeater pump tube set.The pm was further described as, "a black line was immediately noticed in the hose, which when moved with a finger, it turned out to be a hair".This was observed before patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation.A visual inspection was performed, and a loose hair inside the opened primary packaging was observed.The reported condition was verified.The cause of the reported condition could not be determined; however, the possible cause was a manufacturing issue.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
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 Key18837215
MDR Text Key336895864
Report Number1416980-2024-00924
Device Sequence Number1
Product Code NEP
UDI-Device Identifier00085412475721
UDI-Public(01)00085412475721
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
NA
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 04/10/2024
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 NumberH93811
Device Lot Number60434197
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/09/2024
Initial Date FDA Received03/05/2024
Supplement Dates Manufacturer Received03/26/2024
Supplement Dates FDA Received04/10/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2023
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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