FDA.reportPublic FDA data

MAUDE MDR 9861748

MDR report key
9861748
Report number
9616656-2020-00246
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-20
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
1PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPXPEN NEEDLEBECTON DICKINSON AND CO.FMI320559UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2001. O

Event Narratives#

N

Patient 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS. INVESTIGATION CONCLUSION: NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. DEVICE MANUFACTURE DATE: UNKNOWN.

D

Patient 1

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX EXPERIENCED THE CANNULA BREAKING OFF ON THE PATIENT AND NON PATIENT END. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PATIENT CHANGED FROM A COMPETITOR'S PRODUCT TO MICRO FINE PRO. THEN NEEDLE PE AND NPE BREAKAGE OCCURS OFTEN.