FDA.reportPublic FDA data

MAUDE MDR 8416013

MDR report key
8416013
Report number
8416013
Event key
0
Event type
3
Date of event
2019-01-31
Date received
2019-03-13
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
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LUMBAR PUNCTURE TRAYNEEDLE, SPINAL, SHORT TERMCAREFUSION 2200, INCMIA4301C4301C001265024* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-130

Event Narratives#

D

Patient 1

LUMBAR PUNCTURE TRAYS OPENED X 2 AND BOTH FOUND TO HAVE DEBRIS ON THE COLLECTION TUBES. MANUFACTURER RESPONSE FOR ADULT LUMBAR PUNCTURE TRAY, ADULT LUMBAR PUNCTURE TRAY (PER SITE REPORTER). EQUIPMENT FAILURE CALLED TO BD REPRESENTATIVE. ARRANGEMENTS MADE TO RETURN INVOLVED EQUIPMENT TO BD. (B)(6). (B)(4).