FDA.reportPublic FDA data

MAUDE MDR 8051824

MDR report key
8051824
Report number
1917413-2018-03821
Event key
0
Event type
3
Date of event
2018-06-29
Date received
2018-11-08
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
1BD VACUTAINER? PLASTIC URINE COLLECTOR CUPSPECIMEN TRANSPORT AND STORAGE CONTAINERBECTON, DICKINSON & CO.JTW3649417272729R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-0801. O

Event Narratives#

N

Patient 1

INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER?S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

D

Patient 1

IT WAS REPORTED THAT THE BD VACUTAINER? PLASTIC URINE COLLECTOR CUPS WERE "CLOSING BADLY" AND LEAKING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.