FDA.reportPublic FDA data

MAUDE MDR 6984221

MDR report key
6984221
Report number
1917413-2017-00263
Event key
0
Event type
3
Date of event
2016-08-26
Date received
2017-10-27
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? CPT? MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATESPECIMEN COLLECTION TUBEBECTON, DICKINSON & CO.JCF362760UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-2701. O

Event Narratives#

N

Patient 1

DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE OR PHOTO IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER?S INDICATED FAILURE MODE.

D

Patient 1

IT WAS REPORTED THAT A BD VACUTAINER? CPT? MONONUCLEAR CELL PREPARATION TUBE - SODIUM CITRATE??(13X100?MM?/?4ML) TUBES WERE BREAKING DURING CENTRIFUGATION.