BD BBL Sensi-Disc Ciprofloxacin 5 µgRecalls & reported problems across all models

We found 2 models of BD BBL Sensi-Disc Ciprofloxacin 5 µg by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, received between May 5, 2022 and May 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD BBL Sensi-Disc Ciprofloxacin 5 µg recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jan 8, 2024Class IIOpen, Classified

   There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.

   Z-1027-2024 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported BD BBL Sensi-Disc Ciprofloxacin 5 µg problems

BD BBL Sensi-Disc Ciprofloxacin 5 µg models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg 231658

  SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
  1 recall2 reports
• BD BBL™ Sensi-Disc™ Ciprofloxacin 5 µg 231657

  SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
  1 recall0 reports

Recent BD BBL Sensi-Disc Ciprofloxacin 5 µg adverse event reports

The 2 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ CIPROFLOXACIN - 5 ¿G THE ZONE OF INHABITATION WAS LARGER THAN EXPECTED. THIS A REPORT OF 1 OCCURRENCE FOR TWO BATCH NUMBERS (1127037, 1335457). NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER IS REPORTING 231658 HAS LARGER ZONE OF INHIBITION THAN EXPECTED STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER IS REPORTING THEIR 231658 DISCS FROM LOT 1127037 AND 1335457 HAVE A ZONE OF INHIBITION OF >38MM WHEN THE EXPECTED ZONE SIZE SHOULD BE 29MM TO 38MM. NO ORGANISM TYPE WAS SPECIFIED. THE CUSTOMER STATES THEY REPEATED WITH A FRESH ISOLATE AND RESULTS WERE STILL OVER >38MM. THEY RECEIVED A NEW LOT NUMBER OF DISCS, 1335458, AND THE QC PASSED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14464492 ↗
• MalfunctionMay 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE CUSTOMER BD BBL¿ SENSI-DISC¿ CIPROFLOXACIN - 5 G. THIS EVENT OCCURRED 1 TIME(S). AT THIS TIME IT IS UNCLEAR WHETHER OR NOT PATIENT SAMPLES WERE INVOLVED. THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING A ZONE OF INHIBITION FOR THEIR 231658 DISC THAT IS LARGER THAN EXPECTED", "STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER IS REPORTING THEIR 231658 DISCS FROM LOT 1127037 AND 1335457 HAVE A ZONE OF INHIBITION OF >38MM WHEN THE EXPECTED ZONE SIZE SHOULD BE 29MM TO 38MM. NO ORGANISM TYPE WAS SPECIFIED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14289083 ↗

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