PLATE MUELLER HINTON II AGAR SQUARE 20
Report
- Report Number
- 9680577-2024-00021
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- June 26, 2024
- Report Date
- November 18, 2024
- Manufacturer
- BECTON DICKINSON GMBH
- Product Code
- JTZ
- UDI-DI
- 30382902545188
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN BATCH: D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON THE COMPLAINT (B)(4) AGAINST MUELLER HINTON II AGAR, SQUARE, CATALOG NUMBER 254518, LOT NUMBER UNKNOWN WITH RESPECT TO PERFORMANCE. EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT FOR SOME TIME NOW, THEY HAVE REGULARLY NOTICED GROWTH AROUND SXT DISCS FROM ROSCO. COMPARISON WAS PERFORMED WITH PLATES FROM BIORAD, WHERE DEFINED ZONES WITHOUT ANY GROWTH WERE OBSERVED. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS, AND TWO SIMILAR COMPLAINTS WERE REGISTERED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: A BATCH HISTORY REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. SAMPLE ANALYSIS: WITHOUT A LOT NUMBER, RETAIN SAMPLES COULD NOT BE ANALYZED FOR THE GROWTH PROMOTING ABILITY OF THE MEDIUM. HOWEVER, TESTS WERE PERFORMED WITH THREE DIFFERENT LOT NUMBERS OF BD MUELLER HINTON II AGAR USING THE AST METHOD ACCORDING TO EUCAST GUIDELINES. ESCHERICHIA COLI ATCC 25922, ENTEROCOCCUS FAECALIS ATCC 29212 AND STAPHYLOCOCCUS AUREUS ATCC 29213 WERE TESTED WITH SXT SENSI-DISCS FROM BD. ALL INHIBITION ZONES WERE EVALUATED TO BE WITHIN THE EUCAST RANGE. RETURN SAMPLES WERE NOT PROVIDED AND NO PICTURE SAMPLES WERE SHARED. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. NO DEVIATIONS COULD BE DETERMINED NEITHER DURING IN-PROCESS CONTROLS NOR DURING QC RELEASE OF THE CORRESPONDING BATCH NUMBER. INVESTIGATION CONCLUSION: BASED ON THE PROVIDED REPORT AND THE EVALUATION OF RETAIN SAMPLES, THIS COMPLAINT CANNOT BE CONFIRMED FOR A PERFORMANCE ISSUE. RESULTS OF GROWTH PROMOTION TESTS WERE SATISFACTORY.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H.6 ANNEX G CODE & TERM: G01003 - DEVICE INGREDIENT OR REAGENT. H.6. IMDRF ANNEX B GRID: B15 - ANALYSIS OF INFORMATION PROVIDED BY USER/THIRD PARTY. H.6. IMDRF ANNEX B GRID: B05 - TESTING OF DEVICE FROM OTHER LOT/BATCH RETURNED FROM USER. H.6 IMDRF ANNEX C GRID: C13 - OPERATIONAL PROBLEM IDENTIFIED. H.6 IMDRF ANNEX D GRID: D15 - CAUSE NOT ESTABLISHED. H.11 INVESTIGATION SUMMARY THIS MEMO IS TO UPDATE THE FINDINGS ON THE COMPLAINT (B)(4) AGAINST MUELLER HINTON II AGAR, SQUARE, CATALOG NUMBER 254518, LOT NUMBER UNKNOWN WITH RESPECT TO PERFORMANCE. EVENT DESCRIPTION: THE CUSTOMER REPORTED THAT FOR SOME TIME NOW, THEY HAVE REGULARLY NOTICED GROWTH AROUND SXT DISCS FROM ROSCO. COMPARISON WAS PERFORMED WITH PLATES FROM BIORAD, WHERE DEFINED ZONES WITHOUT ANY GROWTH WERE OBSERVED. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS, AND TWO SIMILAR COMPLAINTS WERE REGISTERED FOR THIS CATALOG NUMBER. A TREND COULD NOT BE IDENTIFIED. BATCH HISTORY RECORD (BHR) REVIEW: A BATCH HISTORY REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. SAMPLE ANALYSIS: WITHOUT A LOT NUMBER, RETAIN SAMPLES COULD NOT BE ANALYZED FOR THE GROWTH PROMOTING ABILITY OF THE MEDIUM. HOWEVER, TESTS WERE PERFORMED WITH THREE DIFFERENT LOT NUMBERS OF BD MUELLER HINTON II AGAR SQUARE USING THE AST METHOD ACCORDING TO EUCAST GUIDELINES. ESCHERICHIA COLI ATCC 25922, ENTEROCOCCUS FAECALIS ATCC 29212 AND STAPHYLOCOCCUS AUREUS ATCC 29213 WERE TESTED WITH SXT SENSI-DISCS FROM BD. ALL INHIBITION ZONES WERE EVALUATED TO BE WITHIN THE EUCAST RANGE. RETURN SAMPLES WERE NOT PROVIDED. PICTURE SAMPLES WERE SHARED SHOWING INHIBITION ZONES WITH GROWTH UP TO THE DISC. IN A FURTHER TEST, CLINICAL ISOLATES OF KLEBSIELLA PNEUMONIAE AND ENTEROBACTER CLOACAE PROVIDED BY THE CUSTOMER WERE TESTED: THE CLINICAL ISOLATES WERE TESTED ON BD AND OXOID BATCHES OF MUELLER HINTON II AGAR SQUARE WITH SXT DISKS FROM BOTH BD AND OXOID USING THE AST METHOD ACCORDING TO EUCAST GUIDELINES. ALL STRAINS WERE APPLIED TO BD MUELLER HINTON II AGAR SQUARE LOT NO. 4249029 AND TO OXOID MUELLER HINTON II LOT NO. 4466176 ANTIBIOTIC DISCS BD SXT LOT 3003869 AND OXOID SXT LOT 3794413 WERE ADDED TO THE PLATES. AFTER INCUBATION OF 16-18 HOURS AT 35-37°C UNDER AEROBIC ATMOSPHERE, THE ZONES WERE ANALYZED. IN CASE OF DOUBLE ZONES, THE INNER ZONE WAS USED TO MEASURE THE INHIBITION ZONES ACCORDING TO THE EUCAST GUIDELINES. THE E. CLOACAE AND THE K. PNEUMONIAE ISOLATES SHOWED AN INHIBITION ZONE IN SIZE COMPARABLE FOR BOTH PLATES AND DISCS. NO GROWTH WITHIN THE INHIBITION ZONE WAS OBSERVED. EVALUATION RESULTS: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. NO DEVIATION COULD BE FOUND NEITHER DURING THE QC PERFORMANCE TESTING NOR DURING OUR RETEST ON THE RETAIN SAMPLES OF LOT NUMBER 4249029 WITH THE BD ATCC STRAINS AND THE CUSTOMER STRAINS. INVESTIGATION CONCLUSION: BASED ON THE PROVIDED PICTURE SAMPLES, THIS COMPLAINT IS CONFIRMED FOR A PERFORMANCE ISSUE. HOWEVER, NO DEVIATION COULD BE FOUND NEITHER DURING THE QC PERFORMANCE TESTING NOR DURING OUR RETEST ON THE RETAIN SAMPLES OF LOT NUMBER 4249029 WITH THE BD ATCC STRAINS AND THE CUSTOMER STRAINS. PLEASE REFER TO THE EUCAST READING GUIDE PUBLISHED ON THE EUCAST WEBSITE, WHICH DESCRIBES THAT DOUBLE ZONES CAN APPEAR WITH SXT, AND THE INNER ZONE SHOULD BE USED FOR THE READOUT. FURTHER, EUCAST RECOMMENDS IGNORING FINE HAZE OR FAINT GROWTH UP TO THE DISK WITHIN A ZONE WITH OTHERWISE CLEAR ZONE EDGE. THE EUCAST DISC DIFFUSION METHOD MANUAL (VERSION 12.0, JANUARY 2024) ALSO RECOMMENDS DRYING MOIST PLATES PRIOR TO USE SINCE THIS EXCESSIVE MOISTURE MAY RESULT IN PROBLEMS WITH FUZZY ZONE EDGES AND/OR HAZE WITHIN THE INHIBITION ZONES.
IT WAS REPORTED WHILE USING PLATE MUELLER HINTON II AGAR SQUARE 20 THAT THERE WAS EXCESSIVE GROWTH WHEN USING ROSCO SXT (CO-THRIMOXAZOLE) DISCS. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF PLATES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING PLATE MUELLER HINTON II AGAR SQUARE 20 THAT THERE WAS EXCESSIVE GROWTH WHEN USING ROSCO SXT (CO-THRIMOXAZOLE) DISCS. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF PLATES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
IT WAS REPORTED WHILE USING PLATE MUELLER HINTON II AGAR SQUARE 20 THAT THERE WAS EXCESSIVE GROWTH WHEN USING ROSCO SXT (CO-THRIMOXAZOLE) DISCS. THIS OCCURRED WITH AN UNSPECIFIED NUMBER OF PLATES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2370252 | PLATE MUELLER HINTON II AGAR SQUARE 20 | CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR | JTZ | BECTON DICKINSON GMBH | UNKNOWN | 30382902545188 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |