BD BBL¿ DRYSLIDE¿ OXIDASE
Report
- Report Number
- 2647876-2023-00251
- Event Type
- Malfunction
- Date Received
- October 17, 2023
- Date of Event
- September 13, 2023
- Report Date
- October 23, 2023
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- JTO
- UDI-DI
- 30382902317464
- PMA / PMN Number
- K896398
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM WHEN USING DRYSLIDE OXIDASE CATALOG 231746, BATCH NO.: 2277390 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO TEST PRODUCT FOR PERFORMANCE, VISUAL INSPECTION, AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H3 OTHER TEXT: SEE H.10.
H3. INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM WHEN USING DRYSLIDE OXIDASE CATALOG 231746 BATCH NO.: 2277390. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO TEST PRODUCT FOR PERFORMANCE, VISUAL INSPECTION, AND BATCH RECORD REVIEW WAS PERFORMED ON RETENTION SAMPLES. RETENTION SAMPLES PERFORMED AS EXPECTED. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H3 OTHER TEXT : SEE H10.
THE FOLLOWING UPDATE HAS BEEN MADE: AWARENESS DATE: 19-SEP-2023.
IT WAS REPORTED THAT WHILE USING BD BBL¿ DRYSLIDE¿ OXIDASE, COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM PSEUDOMONAS. NO PATIENT IMPACT REPORTED. "TEST PERFORMS NOT AS EXPECTED: COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM (PSEUDOMONAS) , IT REMAINED COLORLESS DURING USE WERE PATIENT SAMPLES INVOLVED?: YES".
IT WAS REPORTED THAT WHILE USING BD BBL¿ DRYSLIDE¿ OXIDASE, COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM PSEUDOMONAS. NO PATIENT IMPACT REPORTED. "TEST PERFORMS NOT AS EXPECTED: COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM (PSEUDOMONAS) , IT REMAINED COLORLESS. DURING USE. WERE PATIENT SAMPLES INVOLVED? YES."
IT WAS REPORTED THAT WHILE USING BD BBL¿ DRYSLIDE¿ OXIDASE, COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM PSEUDOMONAS. NO PATIENT IMPACT REPORTED. "TEST PERFORMS NOT AS EXPECTED: COLOR CHANGE WAS NOT OBSERVABLE BY OXIDASE POSITIVE ORGANISM (PSEUDOMONAS) , IT REMAINED COLORLESS. DURING USE. WERE PATIENT SAMPLES INVOLVED? YES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96756 | BD BBL¿ DRYSLIDE¿ OXIDASE | DISCS, STRIPS AND REAGENTS, MICROORGANISM DIFFERENTIATION | JTO | BECTON DICKINSON CARIBE LTD. | 2277390 | 30382902317464 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |