BD BBL¿ DRYSLIDE¿ OXIDASE
Received Oct 17, 2023 · Event occurred Sep 13, 2023
Report 2647876-2023-00251 · MDR key 17953732
Device
Generic name
Discs, Strips And Reagents, Microorganism Differentiation
Manufacturer
Becton Dickinson Caribe Ltd.Catalog number
231746
Lot number
2277390
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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.
Description of Event or Problem
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".
Additional Manufacturer Narrative
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.
Description of Event or Problem
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."
Additional Manufacturer Narrative
THE FOLLOWING UPDATE HAS BEEN MADE: AWARENESS DATE: 19-SEP-2023.
Description of Event or Problem
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."