BARD® INLAY® VERSA FIT® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE

Description of Event or Problem

IT WAS REPORTED BY CRITICAL CARE NURSES IN AN ONLINE SURVEY THAT PATIENT EXPERIENCED PAIN AND DISCOMFORT . ALSO STATED THAT PAIN AND DISCOMFORT RESULTED IN PATIENT INJURY REQUIRED MEDICAL OR SURGICAL INTERVENTION. AND ANY ACTION AS A RESULT OF AN ADVERSE EVENT WAS CONSIDERED MEDICAL INTERVENTION PRESCRIBING ANY MEDICATION AS A RESULT OF AN ADVERSE EVENT, SURGERY AS A RESULT OF AN ADVERSE EVENT, ETC. THE DOCTOR IN QUESTION STATED PLEASE DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED FROM AND PATIENT STATED INCREASE AND CHANGE IN PAIN MEDICATION AND THE PATIENT EXPERIENCED PAIN OR DISCOMFORT COMPLICATIONS PRIOR TO DEVICE PLACEMENT OF 4.

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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

CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT PATIENT EXPERIENCED PAIN OR DISCOMFORT ANY DEVICE RELATED ADVERSE EVENTS. ALSO STATED THAT PAIN OR DISCOMFORT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION. AND ANY ACTION AS A RESULT OF AN ADVERSE EVENT WAS CONSIDERED MEDICAL INTERVENTION (E.G. PRESCRIBING ANY MEDICATION AS A RESULT OF AN ADVERSE EVENT, SURGERY AS A RESULT OF AN ADVERSE EVENT, ETC. THE DOCTOR IN QUESTION PLEASE DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED FROM AND PATIENT STATED INCREASE AND CHANGE IN PAIN MEDICATION AND THE PATIENT EXPERIENCED PAIN OR DISCOMFORT COMPLICATIONS PRIOR TO DEVICE PLACEMENT OF 4.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION.THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES: WARNINGS:1. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS.2. THIS IS A SINGLE USE DEVICE. DO NOT RE STERILIZE ANY PORTION OF THIS DEVICE. RE USE AND OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT.PRECAUTIONS:4. EXERCISE CARE. TEARING OF THE STENT CAN BE CAUSED BY SHARP INSTRUMENTS.5. URETERAL STENTS SHOULD BE CHECKED PERIODICALLY FOR SIGNS OF ENCRUSTATION AND PROPER FUNCTION. PERIODIC CHECKS OF THE STENT BY CYSTOSCOPIC AND OR RADIOGRAPHIC PROCEDURES ARE RECOMMENDED AT INTERVALS DEEMED TO BE APPROPRIATE BY THE PHYSICIAN IN CONSIDERATION OF THE INDIVIDUAL PATIENT'S CONDITION AND OTHER PATIENT SPECIFIC FACTORS. WHEN LONG TERM USE IS INDICATED, IT IS RECOMMENDED THAT INDWELLING TIME NOT EXCEED 365 DAYS. THE STENT IS NOT INTENDED AS A PERMANENT INDWELLING DEVICE. DATA ON FILE AT BD.A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED.NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME.CORRECTIONS: E, F, H.UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID.H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.