BD¿ ALCOHOL SWABS
Received Nov 27, 2023 · Event occurred Oct 30, 2023
Report 1920898-2023-00788 · MDR key 18209298
Device
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD¿ ALCOHOL SWABS 100COUNT MULTIPLE WHITE PARTICLES GO EVERYWHERE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER I HAVE A FEW QUESTIONS/CONCERNS ABOUT SOME OF THE BD PRODUCTS I CURRENTLY USE AND HAVE BEEN USING. FIRST, IN REGARDS TO THE ALCOHOL PREP PADS, EVERY SINGLE TIME I TEAR IT OPEN, EVEN RIP APART THE TWO ATTACHED UNOPENED PADS, MULTIPLE WHITE PARTICLES GO EVERYWHERE AND ALL OVER MY HANDS. DO YOU HAVE ANY OTHER TYPE OF PACKAGING TO FIX THIS? IT IS A VERY CONCERNING ISSUE AS THESE PARTICLES POTENTIALLY CAN GET INSIDE THE BODY AND ALL OVER THE SKIN AND MEDICAL EQUIPMENT.
Additional Manufacturer Narrative
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD¿ ALCOHOL SWABS 100 COUNT MULTIPLE WHITE PARTICLES GO EVERYWHERE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER I HAVE A FEW QUESTIONS/CONCERNS ABOUT SOME OF THE BD PRODUCTS I CURRENTLY USE AND HAVE BEEN USING. FIRST, IN REGARDS TO THE ALCOHOL PREP PADS, EVERY SINGLE TIME I TEAR IT OPEN, EVEN RIP APART THE TWO ATTACHED UNOPENED PADS, MULTIPLE WHITE PARTICLES GO EVERYWHERE AND ALL OVER MY HANDS. DO YOU HAVE ANY OTHER TYPE OF PACKAGING TO FIX THIS? IT IS A VERY CONCERNING ISSUE AS THESE PARTICLES POTENTIALLY CAN GET INSIDE THE BODY AND ALL OVER THE SKIN AND MEDICAL EQUIPMENT.
Additional Manufacturer Narrative
NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.