GHIATAS BEADED BREAST LOCALIZATION WIRE
Received Oct 29, 2018 · Event occurred Sep 30, 2018
Report 2020394-2018-01949 · MDR key 8016792
Device
Generic name
Localization Wire
Manufacturer
Bard Peripheral Vascular, Inc.Model number
47920Catalog number
47920
Lot number
REBY2181
Product problems
- Nonstandard Device
- Device Contamination with Chemical or Other Material
- Nonstandard Device
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
NO MEDICAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: NOV2020).
Description of Event or Problem
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE DEVICE ALLEGEDLY WAS NOT CLEAN. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Additional Manufacturer Narrative
H10:A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND IT WAS DETERMINED THAT A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED. HOWEVER, BASED ON THE REPORTED EVENT, A DHR REVIEW WAS REQUESTED TO REVIEW MANUFACTURING RECORDS. THE DHR HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. ONE GHIATAS LOCALIZATION WIRE AND CANNULA WERE RETURNED. THE WIRE WAS RETURNED WITH THE BARB INSIDE THE CANNULA LUMEN. A GEL-LIKE SUBSTANCE WAS NOTED ON BOTH THE WIRE AND THE CANNULA. ALTHOUGH THERE WAS NOT SUFFICIENT SUBSTANCE TO CONDUCT FOURIER TRANSFORM INFRARED SPECTROSCOPY TESTING, THE APPEARANCE OF THE SUBSTANCE WAS CONSISTENT WITH THE LUBRICANT USED IN THE GHIATAS MANUFACTURING PROCESS. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL PRESENT ON DEVICE, SPECIFICALLY EXCESS LUBRICANT (I.E. NONSTANDARD DEVICE). IT WAS DETERMINED THAT EXCESS LUBRICANT WAS APPLIED DURING THE MANUFACTURING PROCESS. THEREFORE, THE ROOT CAUSE IS MANUFACTURING-RELATED. H10: D4 (EXPIRY DATE: NOV2020). 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
IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE DEVICE ALLEGEDLY WAS NOT CLEAN. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.