SWAB ALCOHOL 100 BX 1200
Received Apr 2, 2024
Report 1920898-2024-05070 · MDR key 19028413
Device
Product problems
- Device Markings/Labelling Problem
- Device Markings/Labelling Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CONSUMER REQUESTED INFORMATION REGARDING EXPIRATION ON BD ALCOHOL SWABS. SHE STATED THAT THERE WAS NO EXPIRATION DATE ON THE BOX. CONSUMER WAS NOT ABLE TO LOCATE A LOT # ON THE BOX OR ON THE SWABS. SHE WAS ABLE TO PROVIDE CATALOG # 326895.
Additional Manufacturer Narrative
H3 OTHER TEXT : DEVICE IS NOT AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO H6 (COMPONENT CODE, TYPE OF INVESTIGATION & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.