BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK
Received Dec 6, 2022 · Event occurred Nov 29, 2022
Report 1119779-2022-01464 · MDR key 15925315
Device
Generic name
Dna Probe, Nucleic Acid Amplification, Chlamydia
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
441128Catalog number
441128
Lot number
2152601
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 PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK CONTAMINATION OCCURRED.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: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.
Description of Event or Problem
IT WAS REPORTED THAT BD PROBETEC¿ CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY REAGENT PACK CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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 1119779-2022-01464 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.