TUBE SET, STD VOL, STER H93811

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-24 for TUBE SET, STD VOL, STER H93811 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[184647166] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[184647167] It was reported that a sterile repeater pump tube set leaked. The event was described as? The white spike end was not connected to the tubing?. It was further reported; the bag is spiked and? Put on the compounder and then prime tubing and then within seconds of priming the tubing the spike becomes loose and the liquid spills all over our iv hood (because the spike separates from the tubing)?. It appears? There was no glue or seal that keeping it connected to the tubing?. This issue was identified during compounding. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[188470714] Additional information was added: the lot was manufactured from june 10, 2019 - june 12, 2019. The device was received for evaluation. Unaided visual inspection was performed which revealed the tube set tubing was detached from the tube set spike. No functional testing was performed. The reported condition was verified. The exact cause of the condition could not be determined; however, the probable cause is due to inadequate or lack of adhesive being applied during 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1416980-2020-01663
MDR Report Key9871578
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-26
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1AVAILMED
Manufacturer StreetC. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND.
Manufacturer CityTIJUANA, BAJA CALIFORNIA 22444
Manufacturer CountryMX
Manufacturer Postal Code22444
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTUBE SET, STD VOL, STER
Generic NameSET, I.V. FLUID TRANSFER
Product CodeLHI
Date Received2020-03-24
Model NumberNA
Catalog NumberH93811
Lot Number60188266
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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