BD STERILE CULTURE SWAB
Received Nov 24, 2025 · Event occurred Nov 5, 2025
Report 1119779-2025-05464 · MDR key 23631554
Device
Generic name
Applicator, Absorbent Tipped, Sterile
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
220518
Lot number
KDJV
Product problems
- Contamination
- Incorrect, Inadequate or Imprecise Result or Readings
- Contamination
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING A BD STERILE CULTURE SWABS, AN UNSPECIFIED NUMBER OF BIOLOGICAL CONTAMINATIONS WERE OBSERVED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THIS MEMO SUMMARIZES THE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) ON PRODUCT 220518 (SWAB STERILE FOR ENVIRONMENTAL MONITOR), BATCH NUMBER KDJV. IT WAS REPORTED THAT THERE HAVE BEEN A FEW INSTANCES WHERE LOT KDJV HAD SEVERAL HITS OF GROWTH AFTER PROCESSING THEM HISTORICAL COMPLAINT DATA FOR SKU 220518 SHOWS NO TREND CONCERNING THE REPORTED ISSUE OVER THE PAST YEAR. A REVIEW OF THE BATCH HISTORY RECORD (BHR) FOR THE REPORTED BATCH CONFIRMS THAT ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. ALSO, THE RETAIN SAMPLES FOR REPORTED PRODUCT/BATCH WERE ANALYZED, AND NO ANOMALIES WERE DETECTED. NO PHYSICAL RETURNS OR IMAGES WERE AVAILABLE FOR ANALYSIS. BASED ON THE INVESTIGATION, THE COMPLAINT COULD NOT BE CONFIRMED. AS NO COMPLAINT TRENDS ARE PRESENT AT THIS TIME, NO FURTHER ACTION WILL BE TAKEN. BD WILL CONTINUE TO MONITOR TRENDING FOR THIS ISSUE.
Additional Manufacturer Narrative
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS COPAN, ITALIA. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN SPARKS, MD HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING A BD STERILE CULTURE SWABS, AN UNSPECIFIED NUMBER OF BIOLOGICAL CONTAMINATIONS WERE OBSERVED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCE REPORTED.