GHIATAS LOCALIZATION WIRE
Received Oct 16, 2019
Report 2020394-2019-04016 · MDR key 9198865
Device
Generic name
Biopsy Instrument
Manufacturer
Bard Peripheral Vascular, Inc.Model number
477201Catalog number
477201
Lot number
REDQ4074, UNKNOWN
Product problems
- Signal Artifact/Noise
- Signal Artifact/Noise
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
H10: FOR FIVE OF THE SIX REPORTED MALFUNCTIONS, LOT SAMPLES HAVE BEEN RETURNED TO BD FOR EVALUATION AND ONE WAS NOT RETURNED. AS LOT SAMPLES WERE RETURNED THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLGED SIGNAL ARTIFACT ISSUE. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. THE DEVICE IS LABELED FOR SINGLE USE. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
THIS REPORT SUMMARIZES SIX MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 477201 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED A SIGNAL ARTIFACT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE SIX MALFUNCTIONS, ONE INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT AND FIVE DID NOT INVOLVE A PATIENT. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.
Additional Manufacturer Narrative
FOR FIVE OF THE SIX REPORTED MALFUNCTIONS, THE DEVICES HAVE BEEN RETURNED TO BD FOR EVALUATION AND ONE WILL NOT BE RETURNED. THE COMPANY IS STILL INVESTIGATING THE ISSUE AT THIS TIME. THE DEVICE IS LABELED FOR SINGLE USE.
Description of Event or Problem
THIS REPORT SUMMARIZES SIX MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 477201 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED A SIGNAL ARTIFACT. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. OF THE SIX MALFUNCTIONS, ONE INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT AND FIVE DID NOT INVOLVE A PATIENT. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.