HARVEST TERUMO 51421

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-22 for HARVEST TERUMO 51421 manufactured by Terumo Bct.

Event Text Entries

[95926390] Additional product code: fmf investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10


[95926411] Upon review of the information provided by the distributor, it was discovered that an expired bone marrow aspirate concentrate (bmac) disposable was used on a patient. The bmac disposable set was labeled with an expiration date of 09/01/2017. The procedure was performed on (b)(6) 2017. It is unknown at this time if medical intervention was required for this event. The customer declined to provide patient weight. The bmac disposables set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722028-2017-00514
MDR Report Key7143829
Date Received2017-12-22
Date of Report2017-12-22
Date of Event2017-11-03
Date Mfgr Received2018-10-04
Device Manufacturer Date2016-10-11
Date Added to Maude2017-12-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEVE KERN
Manufacturer Street10810 W. COLLINS AVE
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032392246
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHARVEST TERUMO
Generic NameBMAC2 30-02, BONE MARROW ASPIRATE CONCENTRATE PROCEDUR
Product CodeJQC
Date Received2017-12-22
Catalog Number51421
Lot Number10Z9905
Device Expiration Date2017-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO 80215 US 80215


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-12-22

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