SPINAL/EPIDURAL NEEDLES & TRAYS

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

A SITUATION ANALYSIS WAS PERFORMED FOR THE ISSUE OF INCORRECT ANVISA NUMBER ON THE PACKAGING LABEL OF MATERIAL NUMBER 401387. THE POUCH LABEL FOR THE ANESTHESIA TRAY (401387) DISPLAYS AN INCORRECT ANVISA NUMBER (B)(4) INSTEAD OF THE CORRECT ANVISA NUMBER (B)(4). THE CASE LABEL CORRECTLY REFLECTS THE APPROPRIATE ANVISA NUMBER. PER A REVIEW OF THE LABEL REVISION HISTORY, THE POUCH LABEL WAS INADVERTENTLY UPDATED TO DISPLAY ANVISA NUMBER (B)(4) INSTEAD OF THE CORRECT ANVISA NUMBER (B)(4). THIS ISSUE WAS DETERMINED TO BE CAUSED BY A DATA ERROR WHERE THE INCORRECT ANVISA NUMBER WAS LISTED AFTER THE INFORMATION WAS UPDATED FOR THE DISTRIBUTION CENTER ADDRESS AND CONTACT INFORMATION. THIS TYPE OF EVENT DOES NOT REPRESENT A PRODUCT SAFETY OR PACKAGE INTEGRITY ISSUE THAT WOULD IMPACT THE PRODUCT¿S FORM OR FUNCTION. THERE IS NO IMPACT TO THE FUNCTIONALITY, PRODUCT PERFORMANCE AND NO SAFETY RISKS HAVE BEEN IDENTIFIED. THEREFORE, THIS ISSUE DOES NOT POSE A RISK OR HARM TO THE CLINICIAN OR PATIENT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO FORESEEABLE HEALTH RISK. AFTER ASSESSMENT, FURTHER FIELD ACTION WAS NOT DETERMINED NECESSARY AND THE PRODUCT, INCLUDING THE AFFECTED PRODUCT, HAS BEEN RELEASED FOR DISTRIBUTION.

Description of Event or Problem

THE ANESTHESIA KIT CATALOG, CODE 401387, HAS INCORRECT INFORMATION ON THE LABEL DUE TO AN ERROR WHERE THE ANVISA REGISTRATION NUMBER WAS INADVERTENTLY CHANGED. SA MDS-26-06010 HAS BEEN INITIATED IN TW. HOW WAS THIS ISSUE IDENTIFIED? THE ISSUE WITH THE ANVISA REGISTRATION # WAS IDENTIFIED WHEN A DIRECT DISTRIBUTOR WAS PREPARING SAMPLES FOR A BIDDING PROCESS. AT THAT MOMENT, IT WAS NOTICED THAT THE ANVISA REGISTRATION # IN THE PROCESS DOCUMENTATION WAS DIFFERENT FROM THE ONE ON THE SAMPLE LABEL. PROBABLE CAUSE: PROBABLY THE PACKAGE DESIGNER MADE A "COPY & PAST" ACTION WHEN HE WAS UPDATING ONE OF THE 6 POUCH LABEL GRAPHICS. SO, THE INFORMATION OF (B)(4) POUCH LABEL WAS USED IN THE (B)(4) POUCH LABEL. AN ISSUE IDENTIFIED IN DRAWING (CURRENTLY RELEASED IN SAP) AND ITS IMPACT ON PRODUCT SKU 401387. SPECIFICALLY, THE ANVISA REGISTRATION NUMBER ON THE LABELING IS (B)(4), WHEREAS IT SHOULD BE (B)(4). - SOME LOTS ARE IN THE DISTRIBUTION CENTER (DC), OTHERS ARE COMPLETING STERILIZATION, AND SOME ARE ALREADY WITH DISTRIBUTORS/CUSTOMERS. - LOTS IN DC AND STERILIZATION ARE CURRENTLY UNDER GLOBAL HOLD. - SO FAR, THERE HAVE BEEN NO CUSTOMER COMPLAINTS REGARDING THIS LABELING ERROR. (B)(6) 2025: ¿ BATCH RECEIVED BY DISTRIBUTOR WITH INCORRECT ANVISA NUMBER: LOTE: (B)(4).

Additional Manufacturer Narrative

B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.