BD BBL MYCOPREP- SPECIMEN DIGESTION/DECONTAMINATION KIT,75 ML
Report
- Report Number
- 1119779-2025-05424
- Event Type
- Malfunction
- Date Received
- November 12, 2025
- Date of Event
- October 13, 2025
- Report Date
- March 11, 2026
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- PPM
- UDI-DI
- 00382902408628
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D.2B MEDICAL DEVICE TYPE: PPM.
E4: THE INITIAL REPORTER NOTIFIED THE FDA ON 26-DEC-2025. MEDWATCH REPORT # MW5181691. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 06-NOV-2025. H3 DEVICE EVAL BY MANUFACTURER? YES. INVESTIGATION SUMMARY: THIS MEMO SUMMARIZES THE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) FOR PRODUCT 240862 (KIT MYCOPREP 75 ML), BATCH NUMBER 218079. IT WAS REPORTED BY THE CUSTOMER THAT TWO DAYS AFTER SWITCHING TO LOT # 218079 OF MYCOPREP, ALL SPECIMENS PROCESSED WITH IT FLAGGED POSITIVE WITH BACTERIA, WHICH IS HIGHLY UNUSUAL. THEY DON'T THINK THE MYCOPREP IS CONTAMINATED, BUT INSTEAD THERE'S AN ISSUE WITH THE DECONTAMINATION PROPERTIES OF THE PRODUCT FROM THIS LOT. HISTORICAL COMPLAINT DATA FOR SKU 240862 SHOWS NO TREND CONCERNING THE REPORTED ISSUE OVER THE PAST YEAR. A REVIEW OF THE BATCH HISTORY RECORD (BHR) FOR THE FINISHED PRODUCT LOT CONFIRMED FULL COMPLIANCE. ALL UNITS MET QUALITY SPECIFICATIONS DURING BOTH PRODUCTION AND FINAL RELEASE. RETAIN SAMPLES HAVE BEEN RETRIEVED FOR VISUAL INSPECTION AND BIOBURDEN TESTING, ALL UNITS WERE FOUND TO BE COMPLIANT. NO ISSUES WERE FOUND WITH THE DECONTAMINATION PROPERTIES OF THE PRODUCT. BD RECEIVED TWO BOXES OF 240862 LOT 218079. OF THE TWO BOXES RETURNED, ONE HAD 10 BOTTLES AND THE OTHER HAD 9. NO ISSUES WERE FOUND WITH THE DECONTAMINATION PROPERTIES OF THE PRODUCT. NO IMAGES WERE PROVIDED FOR EVALUATION. BASED ON THE INVESTIGATION, THE ISSUE COULD NOT BE REPRODUCED; THEREFORE, 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.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS SCIENTIFIC DEVICE LABS. 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.
IT WAS REPORTED THAT WHILE USING BBL MYCOPREP- SPECIMEN DIGESTION/DECONTAMINATION KIT, 75 ML, THE CUSTOMER NOTICED ALL PROCESSED SPECIMENS WERE FLAGGED POSITIVE WITH BACTERIA, WHICH WAS HIGHLY UNUSUAL. ACCORDING TO THEM, THE BACTERIAL CONTAMINATION IN THESE CULTURES APPEARS TO BE THE SAME ORGANISMS GROWING IN THE CORRELATING AEROBIC LAB CULTURES AND DO NOT BELIEVE THE MYCOPREP IS CONTAMINATED WITH BACTERIA, ONLY THE DECONTAMINATION PROPERTIES OF THE MYCOPREP MIGHT BE AFFECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 190 OF 200.
IT WAS REPORTED THAT WHILE USING BBL MYCOPREP- SPECIMEN DIGESTION/DECONTAMINATION KIT, 75 ML, THE CUSTOMER NOTICED ALL PROCESSED SPECIMENS WERE FLAGGED POSITIVE WITH BACTERIA, WHICH WAS HIGHLY UNUSUAL. ACCORDING TO THEM, THE BACTERIAL CONTAMINATION IN THESE CULTURES APPEARS TO BE THE SAME ORGANISMS GROWING IN THE CORRELATING AEROBIC LAB CULTURES AND DO NOT BELIEVE THE MYCOPREP IS CONTAMINATED WITH BACTERIA, ONLY THE DECONTAMINATION PROPERTIES OF THE MYCOPREP MIGHT BE AFFECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 190 OF 200.
IT WAS REPORTED THAT WHILE USING BBL MYCOPREP- SPECIMEN DIGESTION/DECONTAMINATION KIT,75 ML, THE CUSTOMER NOTICED ALL PROCESSED SPECIMENS WERE FLAGGED POSITIVE WITH BACTERIA, WHICH WAS HIGHLY UNUSUAL. ACCORDING TO THEM, THE BACTERIAL CONTAMINATION IN THESE CULTURES APPEARS TO BE THE SAME ORGANISMS GROWING IN THE CORRELATING AEROBIC LAB CULTURES AND DO NOT BELIEVE THE MYCOPREP IS CONTAMINATED WITH BACTERIA, ONLY THE DECONTAMINATION PROPERTIES OF THE MYCOPREP MIGHT BE AFFECTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED. THIS IS REPORT 190 OF 200.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2123212 | BD BBL MYCOPREP- SPECIMEN DIGESTION/DECONTAMINATION KIT,75 ML | KIT, IDENTIFICATION, MYCOBACTERIA | PPM | BECTON DICKINSON & CO. (SPARKS) | 218079 | 00382902408628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |