BAYYAN STAT KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-14 for BAYYAN STAT KIT manufactured by Banyan.

Event Text Entries

[4417340] I ordered a banyan stat emergency medication kit 32630. It was shipped with 7 missing medications. Today (b)(6) 2014, fourteen months later i still have not received all items to complete this kit. I was not notified it had back ordered items. I would not have placed the order for an incomplete emergency medication kit. I discovered the missing items when i opened the kit. It seems inappropriate for an emergency medication kit to be sold missing medication.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5035655
MDR Report Key3757097
Date Received2014-04-14
Date of Report2014-04-11
Date of Event2013-02-18
Date Added to Maude2014-04-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBAYYAN STAT KIT
Generic NameEMERGENCY MEDICATION KIT
Product CodeLRR
Date Received2014-04-14
Lot Number32630
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerBANYAN
Manufacturer AddressPALANTINE TX 60055 US 60055


Patients

Patient NumberTreatmentOutcomeDate
10 2014-04-14

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