FDA.reportPublic FDA data

MAUDE MDR 7485428

MDR report key
7485428
Report number
2243072-2018-00743
Event key
0
Event type
3
Date of event
2013-01-22
Date received
2018-05-03
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#

Contact
BDX BRETT WILKO
Address
9450 SOUTH STATE STREET SANDY UT 84070 US
Phone
801-801-8015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BD VACUTAINER? EDTAN/ABECTON DICKINSONPJEUNKNOWNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-0301. O

Event Narratives#

N

Patient 1

THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE AWARENESS DATE HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER: ADDRESS UNAVAILABLE. (B)(6) ADDRESS USED. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

D

Patient 1

IT WAS REPORTED THAT BD VACUTAINER? EDTA HAD ISSUES WITH UNDERFILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.