QBC AUTOREAD PLUS UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-05 for QBC AUTOREAD PLUS UNK manufactured by Becton Dickinson & Co.

Event Text Entries

[102926] Rptr states: there are serious design flaws in the centrifuge for the capillary tubes (qbc centrifuge): 1) the instrument is designed to operate without the protective cover in place. This can lead to spillage of blood into the centrifuge and it can never be adequately cleaned. Futhermore the capillary tube containing blood is splintered into sharp pieces which can hurt somebody trying to clean the centrifuge. 2) the centrifuge is very noisy and does not permit any other activity in the office while it is on. These flaws should be corrected. Rptr's surprised that such a poor quality product has been let out of co's design labs! Rptr would recommend that co design the centrifuge with <60db noise level and also prevent the switching on of the machine unless the coverplate is securely screwed in. Co could do this with a microswitch activated by the knob of the coverplate (ie. , if the coverplate is not screwed on, the centrifuge should not work). While co could possibly get by with explanations such as "you must read the instructions before use," etc, rptr feels, when dealing with human blood, one must take care to build in redundancy into design, to eliminate serious contamination and risk of injury to personnel. Rptr is surprised that the fda approved this device. Rptr has at least two messages on the tech support line and no one has called back. Rptr would like to return the instrument for full refund, unless these problems are promptly fixed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002036
MDR Report Key130976
Date Received1997-11-05
Date of Report1997-10-14
Date Added to Maude1997-11-13
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 FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameQBC AUTOREAD PLUS
Generic NameCENTRIFUGE
Product CodeGHK
Date Received1997-11-05
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key128040
ManufacturerBECTON DICKINSON & CO
Manufacturer Address1 BECTON DR. FRANKLIN LAKES NJ 074171880 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-11-05

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