FDA.reportPublic FDA data

MAUDE MDR 5249587

MDR report key
5249587
Report number
MW5058076
Event key
0
Event type
3
Date received
2015-11-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
110% NEUTRAL BUFFERED FORMALIN10% NEUTRAL BUFFERED FORMALINRICHARD ALLAN SCIENTIFIC OF THERMO SCIENTIFICIFP594801* *
2UNKCONTAINERCARDINAL HEALTHMMKC4320-450B MNF* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-190

Event Narratives#

D

Patient 1

SINCE (B)(6) 2014, THERE HAS BEEN AN INCREASE IN EXPOSURE TO FORMALIN DUE TO CONTAINER SPILLS AND LEAKAGE FROM THE PREFILLED SPECIMEN CONTAINERS. LEAKING CONTAINERS OCCUR BOTH ON THE INITIAL HANDLING OF CONTAINERS BY THE MATERIALS MANAGEMENT STAFF AS WELL AS WHEN RESEALING AFTER THE SPECIMEN HAS BEEN ADDED. THE MATERIALS MANAGEMENT TEAM HAS COMMUNICATED WITH THE VENDOR AND RETURNED TWO SPECIMEN CONTAINERS TO THE VENDOR FOR EVAL.