PLATE MUELLER HINTON II AGAR
Report
- Report Number
- 1119779-2022-01337
- Event Type
- Malfunction
- Date Received
- October 26, 2022
- Date of Event
- October 19, 2022
- Report Date
- November 2, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- JTZ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: 251275 #2200275. WE COULDN'T CONFIRM THIS ISSUE AS A REPORT BECAUSE NO PHOTO AND RETURNED SAMPLE. COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS LOT. AT THIS TIME. DEVICE HISTORY RECORD REVIEW (DHR), DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. IT INCLUDES BIOBURDEN TESTING. A VISUAL INSPECTION WAS PERFORMED ON 20 RETENTION SAMPLES OF THIS LOT. AS A RESULT, NO CONTAMINATION WAS OBSERVED. THE ROOT CAUSE FOR THIS COULD NOT BE DETERMINED
IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON II AGAR CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND THAT THE MEDIA WAS CONTAMINATED."
IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON II AGAR CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER FOUND THAT THE MEDIA WAS CONTAMINATED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2453072 | PLATE MUELLER HINTON II AGAR | NA | JTZ | BECTON, DICKINSON & CO. (SPARKS) | 2200275 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |