BD BBL¿ VOGES-PROSKAUER B REAGENT DROPPER
Received Mar 24, 2023 · Event occurred Mar 6, 2023
Report 1119779-2023-00328 · MDR key 16612373
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton, Dickinson & Co. (sparks)Model number
261193Catalog number
261193
Lot number
UNKNOWN
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
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: THIS MEMO SERVES TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) ON PRODUCT 261193 (DROPPER VOGES-PROSKAUER B), LOT NUMBER UNKNOWN, WHERE IT WAS OBSERVED THAT THERE WAS A BOX OF MIXED DROPPER BOTTLES. EVENT DESCRIPTION: " CUSTOMER REPORTS THAT WHEN THE END USER OPENED THE PACK, THERE WAS A MIXTURE OF 261193 AND TUBES OF ANOTHER CHEMICAL WITHIN THE BOX." COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. SAMPLE ANALYSIS: THE PHOTOS THAT WERE PROVIDED DID NOT SHOW ANY DEFECTS. THE RETENTION SAMPLES COULD NOT BE INSPECTED AS A LOT NUMBER WAS NOT PROVIDED. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. NO COMPLAINT TREND EXISTS ON THIS ISSUE WITH THIS PRODUCT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. AS NO DEVIATIONS WERE OBSERVED IN THE INVESTIGATION, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. HOWEVER, BD WILL CONTINUE TO MONITOR FOR TRENDING.
Description of Event or Problem
IT WAS REPORTED THAT UPON OPENING 8 PACKS TUBES FROM A DIFFERENT CHEMICAL BOX WERE MIXED WITH PRODUCT BD BBL¿ VOGES-PROSKAUER B REAGENT DROPPER. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT WHEN THE END USER OPENED THE PACK, THERE WAS A MIXTURE OF 261193 AND TUBES OF ANOTHER CHEMICAL WITHIN THE BOX.
Description of Event or Problem
IT WAS REPORTED THAT UPON OPENING 8 PACKS TUBES FROM A DIFFERENT CHEMICAL BOX WERE MIXED WITH PRODUCT BD BBL¿ VOGES-PROSKAUER B REAGENT DROPPER. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT WHEN THE END USER OPENED THE PACK, THERE WAS A MIXTURE OF 261193 AND TUBES OF ANOTHER CHEMICAL WITHIN THE BOX.
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.