FDA.reportPublic FDA data

MAUDE MDR 9850591

MDR report key
9850591
Report number
2243072-2020-00435
Event key
0
Event type
3
Date of event
2020-03-09
Date received
2020-03-18
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#

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
1UNSPECIFIED BD HEPARIN TUBEBLOOD SPECIMEN COLLECTION DEVICEBECTON DICKINSONJKAUNKNOWNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1801. O

Event Narratives#

N

Patient 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: 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. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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 AN UNSPECIFIED BD HEPARIN TUBE GAVE ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "-IT IS REPORTED CUSTOMER EXPERIENCED ERRONEOUS RESULTS. PAS SURVEY VERBIAGE RECEIVED, - "TWO YEARS AGO THE GREEN TOP HEPARIN TUBE YIELDED FALSE TROPONIN LEVELS. UNKNOWN IF FALSE HIGH OR LOW. "PACKS" OF THESE TUBES WERE RETURNED TO EITHER BD OR DISTRIBUTOR. NO FURTHER INFO WAS AVAILABLE." PAS SURVEY ATTACHED."