BD STERILE CULTURE SWAB
Received May 2, 2025 · Event occurred Apr 23, 2025
Report 1119779-2025-00343 · MDR key 21950950
Device
Generic name
Applicator, Absorbent Tipped, Sterile
Manufacturer
Becton Dickinson & Co. (sparks)Catalog number
220518
Lot number
D2MJ
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY - THIS MEMO SERVES TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) ON PRODUCT 220518 (SWAB STERILE FOR ENVIRONMENTAL MONITORING), LOT NUMBER D2MJ, WHERE IT WAS OBSERVED THAT THERE WAS CONTAMINATION FROM MICROORGANISMS. EVENT DESCRIPTION: IT WAS REPORTED THAT MICROORGANISMS ARE FREQUENTLY DETECTED IN POST-USE MICROBIAL TESTS. COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD DOES NOT INDICATE ANY MANUFACTURING ISSUES. SAMPLE ANALYSIS: NO PHOTOS OR RETURNS WERE AVAILABLE. THE RETENTION SAMPLES DID NOT EXHIBIT ANY DEFECTS. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, NO DEFECT WAS OBSERVED. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS. THERE IS NO COMPLAINT TREND PRESENT FOR THIS ISSUE WITH THIS PRODUCT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. AS NO DEVIATIONS WERE OBSERVED IN THE INVESTIGATION, NO CORRECTIVE OR PREVENTIVE ACTIONS ARE INDICATED AT THIS TIME. NO FURTHER ACTIONS WILL BE TAKEN. BD WILL CONTINUE TO MONITOR FOR TRENDING.
Description of Event or Problem
REPORT 2 OF 10: IT WAS REPORTED WHILE USING A BD STERILE CULTURE SWABS THAT BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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
REPORT 2 OF 10: IT WAS REPORTED WHILE USING A BD STERILE CULTURE SWABS THAT BIOLOGICAL CONTAMINATION WAS OBSERVED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.