FDA.reportPublic FDA data

MAUDE MDR 3029303

MDR report key
3029303
Report number
1213649-2013-00006
Event key
0
Event type
3
Date of event
2012-03-21
Date received
2013-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ROBERT TRAHAN
Address
2080 PLAINFIELD PIKE CRANSTON RI 02921 US
Phone
401-401-4019
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OSGOOD BIOPSY NEEDLENEEDLECADENCE INDWO7557755775153-02R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-2701. O

Event Narratives#

D

Patient 1

ON (B)(6) 2012, DURING A BONE MARROW BIOPSY PROCEDURE, THE NEEDLE BENT THE FIRST TIME IT WAS USED. IT WAS ALSO REPORTED THAT TWO OTHER SIMILAR CADENCE NEEDLE DEVICES USED DURING THIS PROCEDURE ALSO BENT WHEN USED FOR THE FIRST TIME. THREE ATTEMPTS HAVE BEEN MADE TO RECEIVE ADD'L INFO ABOUT THE INCIDENT, BUT NONE HAS BEEN RECEIVED TO DATE. IF FURTHER INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

N

Patient 1

CADENCE ACKNOWLEDGES THIS REPORT DOES NOT MEET THE THIRTY DAY REPORTING REQUIREMENT. THIS WAS UNINTENTIONAL. THIS REPORT IS BEING FILED AFTER IT WAS IDENTIFIED AS NON-COMPLIANT DURING AN INTERNAL REVIEW OF OUR COMPLAINT FILES. WHILE THE ACTUAL DEVICE WAS NOT RETURNED FOR EVAL, THE REPORTED NEEDLE BENT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. THE CAUSE OF THE NEEDLE BENT COULD NOT BE DETERMINED FROM THE PHOTOGRAPH.