FDA.reportPublic FDA data

MAUDE MDR 3969951

MDR report key
3969951
Report number
3969951
Event key
0
Event type
3
Date of event
2014-06-30
Date received
2014-07-28
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
1MIDSTREAM URINE COLLECTION KITURINE COLLECTION KIT (EXCLUDES HIV TESTING)BARD MEDICALOIE*842904* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-280

Event Narratives#

D

Patient 1

URINE SPECIMEN CONTAINER IN CATH KIT IS UNABLE TO TOLERATE BEING SENT BY THE PNEUMATIC TUBE SYSTEM WITHOUT FREQUENT LEAKAGE DUE TO CAP LOOSENING. PURCHASING HAS BEEN WORKING ON THIS, BUT HAS BEEN UNABLE TO OBTAIN AN IMPROVED PRODUCT. WHEN CAP LOOSENS, SPECIMEN CONTENTS ARE SPILLED INSIDE THE PNEUMATIC TUBE SHUTTLE, CREATING A BIO HAZARD EXPOSURE AND REQUIRING ANOTHER SPECIMEN TO BE OBTAINED FROM THE PATIENT.