BD FOX¿ EXTRACTION TUBES
Received Dec 6, 2022 · Event occurred Nov 29, 2022
Report 1119779-2022-01463 · MDR key 15925291
Device
Generic name
Dna Reagents, Neisseria
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
441129Catalog number
441129
Lot number
224293
Product problems
- Contamination
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT BD FOX¿ EXTRACTION TUBES CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CONSECUTIVE ROUNDS OF DECONTAMINATION, CUSTOMER FOUND CONTAMINATION ON PRODUCT DURING AN ENVIRONMENTAL RUN AFTER CONSECUTIVE ROUNDS OF DECONTAMINATION OF THE LAB, CUSTOMER SWABBED THE INSIDE OF STATED REAGENT BOX AFTER USING FRESH PPE AND BEFORE THE REAGENT BOXES WERE PUT INTO THE LAB. CUSTOMER IS NOT RULING OUT THAT THE BOXES OF REAGENTS WERE CONTAMINATED BEFORE DELIVERY.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2022-01463 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
IT WAS REPORTED THAT BD FOX¿ EXTRACTION TUBES CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CONSECUTIVE ROUNDS OF DECONTAMINATION, CUSTOMER FOUND CONTAMINATION ON PRODUCT DURING AN ENVIRONMENTAL RUN AFTER CONSECUTIVE ROUNDS OF DECONTAMINATION OF THE LAB, CUSTOMER SWABBED THE INSIDE OF STATED REAGENT BOX AFTER USING FRESH PPE AND BEFORE THE REAGENT BOXES WERE PUT INTO THE LAB. CUSTOMER IS NOT RULING OUT THAT THE BOXES OF REAGENTS WERE CONTAMINATED BEFORE DELIVERY.