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MAUDE MDR 2749373

MDR report key
2749373
Report number
2749373
Event key
0
Event type
3
Date of event
2012-08-29
Date received
2012-09-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CARDINAL CUSTOM C-SECTION KITCESAREAN SECTION KIT, ID BANDSCARDINAL HEALTHOHMSRHPG23CSA01*152213 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-09-180

Event Narratives#

D

Patient 1

THE NURSE OPENED THE CUSTOM C-SECTION DELIVERY PACK AND FOUND THE INFANT/FAMILY ARM BANDS LOOSE INSIDE THE KIT. 2 PAIR OF BANDS MATCHED INSTEAD OF ALL FOUR. THE NUMBERS NEED TO MATCH IN ORDER FOR THE INFANT TO BE GIVEN TO THE CORRECT FAMILY.THIS IS THE SECOND OCCURRENCE THAT WE HAVE IDENTIFIED.======================MANUFACTURER RESPONSE FOR INFANT AND FAMILY ID BANDS IN A C- SECTION PACK, CARDINAL (PER SITE REPORTER).======================THE MANUFACTURER IS VERY APOLOGETIC AND ALARMED. THE SALES REP SENT IN A WHOLE CASE OF NEW ARMBANDS SO NURSING CAN DISCARD ANY MORE MISS-MATCHED BANDS. CARDINAL HAS COMMITTED TO FOLLOWING UP ON THE FAILURE.