inforMED
MalfunctionLEE

BD CYTOLOGY STAIN KIT

Received Oct 12, 2023 · Event occurred Aug 31, 2023

Report 3008007472-2023-00034 · MDR key 17928076

Device

Generic name

Stains, Dye Solution

Catalog number

491458

Lot number

3074390

Product problems

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

Patient

Unknown

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

Narrative

Description of Event or Problem

EIT WAS REPORTED THAT WHILE USING BD CYTOLOGY STAIN KIT, THERE IS MISSING LABEL INFORMATION ON ONE PACK. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:(B)(6) NO MENTIONED ON THE PACK OF CYTOLOGY STAIN KIT, CAT# 491458 IS (B)(6) 2023.. WHEREAS THE EXPIRY DATE MENTIONED ON THE HEMATOXYLIN STAIN 0.75: WITH LOT# 3038847 AND EA/OG COMBO STAIN: WITH LOT# 3038858 IS 31-01-2024."

Additional Manufacturer Narrative

(B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3008007472-2023-00034 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

Description of Event or Problem

EIT WAS REPORTED THAT WHILE USING BD CYTOLOGY STAIN KIT, THERE IS MISSING LABEL INFORMATION ON ONE PACK. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "XPIRY NO MENTIONED ON THE PACK OF CYTOLOGY STAIN KIT, CAT# (B)(4) IS 31-08-2023. WHEREAS THE EXPIRY DATE MENTIONED ON THE HEMATOXYLIN STAIN 0.75: WITH LOT# 3038847 AND EA/OG COMBO STAIN: WITH LOT# 3038858 IS 31-01-2024."