BD BBL¿ CATALASE REAGENT DROPPER
Received Aug 4, 2023 · Event occurred Jul 18, 2023
Report 1119779-2023-00838 · MDR key 17466875
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton, Dickinson & Co. (sparks)Catalog number
261203
Lot number
B01F122M
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
H6. INVESTIGATION SUMMARY: 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 DHR DID NOT REVEAL ANY MANUFACTURING ISSUES. SAMPLE ANALYSIS: AN INSPECTION OF THE PHOTO DID THE NOTED DEFECT. AN INSPECTION OF THE RETENTIONS WAS SATISFACTORY. THE ERP SYSTEM THAT GENERATED THE CERTIFICATE HAD THE WRONG EXPIRATION DATE. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, THE DEFECT WAS OBSERVED ON THE PHOTO AND ERP SYSTEM. THE WRONG DATA WAS ENTERED INTO THE ERP SYSTEM WHICH CAUSED THE NOTED DISCREPANCY. A COMPLAINT TREND IS NOT PRESENT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED. THE EXPIRATION DATE WAS CORRECTED IN THE ERP SYSTEM AND THE CERTIFICATE CORRECTED. A COMPLAINT TREND ON THIS ISSUE IS NOT PRESENT WITH THIS PRODUCT. NO FURTHER ACTIONS WILL BE TAKEN AS THIS IS AN ISOLATED INCIDENT. BD WILL CONTINUE TO MONITOR FOR TRENDING.
Description of Event or Problem
IT WAS REPORTED THAT BD BBL¿ CATALASE REAGENT DROPPER DATES OF EXPIRATION ON BOX AND BOTTLE DO NOT MATCH THE COC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED CERTIFICATE OF COMPLIANCE AND SHIPMENT DETAIL DOCUMENT WITH LOT# B01F122M DATED (B)(6) 2024 BUT THE BOX AND DROPPERS HAS LOT# B01F122M DATED (B)(6) 2024. SPOKE WITH CX AND SHE VERIFIED FOR LOT# B01F122M HAS DATE (B)(6) 2024 WOULD YOU SEND OUR CUSTOMER A NO CHARGE REPLACEMENT WITH A BOX THAT HAS LOT# B01F122M HAS DATED (B)(6) 2024.
Additional Manufacturer Narrative
H.3. 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 BBL¿ CATALASE REAGENT DROPPER DATES OF EXPIRATION ON BOX AND BOTTLE DO NOT MATCH THE COC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED CERTIFICATE OF COMPLIANCE AND SHIPMENT DETAIL DOCUMENT WITH LOT# B01F122M DATED JULY 2024 BUT THE BOX AND DROPPERS HAS LOT# B01F122M DATED JUNE 2024. SPOKE WITH CX AND SHE VERIFIED FOR LOT# B01F122M HAS DATE JULY 2024. WOULD YOU SEND OUR CUSTOMER A NO CHARGE REPLACEMENT WITH A BOX THAT HAS LOT# B01F122M HAS DATED JULY 2024.