PLATE BRUCELLA AGAR 5% HBL 90MM 20
Report
- Report Number
- 9680577-2023-00016
- Event Type
- Malfunction
- Date Received
- April 19, 2023
- Date of Event
- March 28, 2023
- Report Date
- May 31, 2023
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- KZI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G5. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ BRUCELLA AGAR WITH 5% HORSE BLOOD, CATALOG NUMBER 221547 AND 221548 WITH 510K # PREAMENDMENT.
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 9680577-2023-00016 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. H3 OTHER TEXT : SEE H.10.
H.6 INVESTIGATION SUMMARY: EVENT DESCRIPTION: THE CUSTOMER REPORTED CONTAMINATED BRUCELLA BLOOD AGAR PLATES, PRODUCT CODE 255027, LOT NUMBER 3037294, EXPIRY 09.05.2023. COMPLAINT HISTORY REVIEW: THE COMPLAINTS TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. SIMILAR COMPLAINTS WERE REPORTED DURING THAT PERIOD ON THIS PRODUCT AND BATCH NUMBER. HOWEVER, A TREND COULD NOT BE DETECTED, AND IT APPEARS TO BE A SINGLE INCIDENT. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY, AND NO DEVIATIONS WERE OBSERVED. SAMPLE ANALYSIS: RETAIN SAMPLES WERE REVIEWED AND PLATES WITH CONTAMINATION COULD BE IDENTIFIED. NEITHER RETURN NOR PICTURE SAMPLES WERE PROVIDED BY THE CUSTOMER FOR ANALYSIS. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. PLEASE NOTE THAT THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY; THEREFORE, AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. ACCORDING TO OUR HIGH-QUALITY STANDARD, WE ONLY RELEASE PRODUCT BATCHES TO THE MARKET WITH AN AQL (ACCEPTABLE QUALITY LEVEL) = 0,65. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE A CONTAMINATED PLATE. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT WHILE USING THE PLATE BRUCELLA AGAR 5% HBL 90MM 20 THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE (B)(4) BOXES OF CONTAMINATED BRUCELLA BLOOD AGAR PLATES, PRODUCT CODE 255027, LOT NUMBER 3037294, EXPIRY 09.05.2023. IT WAS BIOLOGICAL CONTAMINATION AND THE PLATES HAVE NOW BEEN DISCARDED.
IT WAS REPORTED THAT WHILE USING THE PLATE BRUCELLA AGAR 5% HBL 90MM 20 THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 9 BOXES OF CONTAMINATED BRUCELLA BLOOD AGAR PLATES, PRODUCT CODE 255027, LOT NUMBER 3037294, EXPIRY 09.05.2023. IT WAS BIOLOGICAL CONTAMINATION AND THE PLATES HAVE NOW BEEN DISCARDED.
IT WAS REPORTED THAT WHILE USING THE PLATE BRUCELLA AGAR 5% HBL 90MM 20 THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 9 BOXES OF CONTAMINATED BRUCELLA BLOOD AGAR PLATES, PRODUCT CODE 255027, LOT NUMBER 3037294, EXPIRY 09.05.2023. IT WAS BIOLOGICAL CONTAMINATION AND THE PLATES HAVE NOW BEEN DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1520169 | PLATE BRUCELLA AGAR 5% HBL 90MM 20 | CULTURE MEDIA, ENRICHED | KZI | BECTON DICKINSON GMBH | 3037294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |