FDA.reportPublic FDA data

MAUDE MDR 7809711

MDR report key
7809711
Report number
2243072-2018-01137
Event key
0
Event type
3
Date of event
2018-08-07
Date received
2018-08-23
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? R 87 V INFUSION SETINFUSION SETBECTON DICKINSONFPK396373SEE H.10Y *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-2301. O

Event Narratives#

N

Patient 1

THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. 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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1007785, EXPIRATION DATE: 2021-02-01, MANUFACTURE DATE: 2018-03-03. MEDICAL DEVICE LOT #: 1007786, EXPIRATION DATE: 2021-02-01, MANUFACTURE DATE: 2018-03-06. INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT BD? R 87 V INFUSION SET LEAKED FROM UNDERNEATH THE DRIPPING CHAMBER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.