inforMED
MalfunctionLKB

BD ALCOHOL SWABS100 BX 1200

Received Jul 16, 2021 · Event occurred Jun 18, 2021

Report 1920898-2021-00772 · MDR key 12185985

Device

Generic name

Pad, Alcohol, Device Disinfectant

Catalog number

326895

Lot number

8191582

Product problems

  • Device Markings/Labelling Problem
  • Device Markings/Labelling Problem

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INVESTIGATION SUMMARY: 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. DUE TO THIS BATCH BEING MADE IN 2008 AND FILES ARE RETAINED FOR 7 YEARS, NO DHR REVIEW CAN BE COMPLETED. 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.

Description of Event or Problem

IT WAS REPORTED THAT PRIOT TO USE, THE EXPIRATION DATE WAS DISCOVERED TO BE MISSING ON A BOX OF BD ALCOHOL SWABS100 BX 1200.   THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEALTH DEPARTMENT EMPLOYEE CALLED TO INQUIRE ABOUT EXPIRATION DATE ON A BOX OF ALCOHOL SWABS. CALLER STATED PRODUCT HAD NOT BEEN USED. CALLER WAS ABLE TO LOCATE CATALOG #, LOT # AND COPYRIGHT YEAR; USING LOT # AND YEAR OF COPYRIGHT DETERMINED EXPIRATION DATE.