BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR
Report
- Report Number
- 9614033-2024-00067
- Event Type
- Malfunction
- Date Received
- October 4, 2024
- Date of Event
- September 5, 2024
- Report Date
- August 14, 2025
- Manufacturer
- BECTON DICKINSON DE MEXICO
- Product Code
- JSH
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4201445, D4. MEDICAL DEVICE EXPIRATION DATE: 11-OCT-2024, D4. UNIQUE IDENTIFIER (UDI) #: N/A, H4. DEVICE MANUFACTURE DATE: 19-JUL-2024. D4. MEDICAL DEVICE LOT #: 4201102, D4. MEDICAL DEVICE EXPIRATION DATE: 11-OCT-2024, D4. UNIQUE IDENTIFIER (UDI) #: N/A, H4. DEVICE MANUFACTURE DATE: 19-JUL-2024. E1. INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 4201445. B5. IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR, THERE WERE AN UNKNOWN NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR (B)(4).
INVESTIGATION SUMMARY THE COMPLAINT REPORT RECEIVED FOR CATALOG 252631 IS CLASSIFIED AS CONFIRMED FOR THE PRESENCE OF CONTAMINATION BASED ON THE EVIDENCE SHARED BY THE CUSTOMER. REVIEW OF BATCH HISTORY RECORDS: THE BATCH FILE REPORTED BY THE CUSTOMER WAS REVIEWED, AND IT WAS OBSERVED THAT, ACCORDING TO THE COLLECTED INFORMATION, THE DEFINED PROCESS CONTROLS WERE CARRIED OUT, AND THE ABSENCE OF CONTAMINATED PRODUCT WAS VERIFIED. REVIEW OF COMPLAINT HISTORY: A REVIEW OF THE COMPLAINT HISTORY FOR A PERIOD OF 2 YEARS WAS CONDUCTED, IDENTIFYING A SERIES OF REPORTS NOT ATTRIBUTABLE TO IN-PLANT HANDLING, SO NO TREND IN THE DEFECT IS IDENTIFIED. RETURNED SAMPLE ANALYSIS: FOR IMAGE 1, THE CUSTOMER PRESENTS AN ANALYSIS FOR THE REPORTED BATCHES. FOR ONE OF THE PLATES, MICROBIOLOGICAL GROWTH IS OBSERVED (BATCH 4201102). BATCH 4201445: THE CUSTOMER PRESENTS 2 PRODUCT PLATES WITH EVIDENCE OF MICROBIOLOGICAL GROWTH. BATCH 4201102: FOR THIS BATCH, THE CUSTOMER PRESENTS EVIDENCE OF 2 PLATES WITH MICROBIAL GROWTH. FOR THE FIRST PLATE, THE PRESENCE OF A SINGLE CFU IS OBSERVED, WHILE THE SECOND PHOTOGRAPH SHOWS MORE EXTENSIVE MICROBIOLOGICAL GROWTH. FOR BOTH PRODUCT BATCHES, THE CUSTOMER IDENTIFIES THE BACTERIUM ACINETOBACTER JOHNSONII. HOWEVER, THIS CANNOT BE CONFIRMED DUE TO THE LACK OF RETURNED PHYSICAL SAMPLES. THIS MICROORGANISM IS COMMONLY FOUND IN THE ENVIRONMENT. RETENTION SAMPLE ANALYSIS: IN ACCORDANCE WITH THE LABORATORY ANALYSIS REQUESTS, THE VERIFICATION OF THE APPEARANCE AND BIOLOGICAL LOAD OF THE RETENTION SAMPLES WAS CARRIED OUT, OBTAINING SATISFACTORY RESULTS FOR BOTH TESTS AS NO EVIDENCE OF MICROBIOLOGICAL GROWTH OR VARIATIONS IN THE APPEARANCE OF THE CULTURE MEDIUM FOR EACH BATCH WAS OBSERVED. CONCLUSION: THE COMPLAINT REPORT RECEIVED FOR CATALOG 252631 IS CLASSIFIED AS CONFIRMED, AS THE PRESENCE OF 2 SUPERFICIALLY CONTAMINATED PLATES IS OBSERVED FOR EACH REPORTED BATCH. THIS DEFECT IS WITHIN THE ESTABLISHED AQL. ACCORDING TO THE DOCUMENT REVIEW, ALL DEFINED CONTROLS FOR THE PRODUCTS WERE MET, COMPLYING WITH THE ACCEPTANCE CRITERIA FOR APPEARANCE AND WITHOUT CONTAMINATION FOR THE REST OF EACH BATCH. THEREFORE, IT IS POSSIBLE TO AFFIRM THAT THE FAILURE WAS DUE TO A SPECIFIC EVENT IN TIME. HOWEVER, THE PRESENCE OF A CONTAMINATED PACKAGE (1 PLATE) BASED ON THE BATCH SIZE IS CONSIDERED WITHIN THE AQL (ACCEPTANCE QUALITY LEVEL), WHICH IS DEFINED AS 2.5 FOR MAJOR DEFECTS OF SUPERFICIAL BACTERIAL CONTAMINATION. ON THE OTHER HAND, SINCE THE PRODUCT IS NOT CONSIDERED STERILE, IT IS POSSIBLE THAT DURING THE STORAGE PROCESS, A CFU MAY BE CARRIED OVER DUE TO CONDENSATES GENERATED DURING STORAGE OR DISTRIBUTION. BD WILL CONTINUE TO MONITOR TRENDS.
IT WAS REPORTED THAT BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR WAS CONTAMINATED WITH ACINETOBACTER JOHNSONII. CONTAMINATION WAS OBSERVED DURING AND PRIOR TO USE. APPROXIMATELY ONE HUNDRED CONTAMINATED PLATES (100) WERE FROM LOT 4201445 AND FIFTY (50) CONTAMINATED PLATES WERE FROM LOT 4201102. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR, THERE WERE AN UNKNOWN NUMBER OF FALSE RESULTS DUE TO CONTAMINATION. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED THAT BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR WAS CONTAMINATED WITH ACINETOBACTER JOHNSONII. CONTAMINATION WAS OBSERVED DURING AND PRIOR TO USE. APPROXIMATELY ONE HUNDRED CONTAMINATED PLATES (100) WERE FROM LOT 4201445 AND FIFTY (50) CONTAMINATED PLATES WERE FROM LOT 4201102. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2602474 | BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR | CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL | JSH | BECTON DICKINSON DE MEXICO | SEE H11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |