BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML
Report
- Report Number
- 1119779-2023-00557
- Event Type
- Malfunction
- Date Received
- May 16, 2023
- Date of Event
- April 26, 2023
- Report Date
- September 5, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (SPARKS)
- Product Code
- PPM
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL FACILITY NAME: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 407122. MEDICAL DEVICE EXPIRATION DATE: 01-OCT-2023. DEVICE MANUFACTURE DATE: 14-OCT-2022. MEDICAL DEVICE LOT#: 396122. MEDICAL DEVICE EXPIRATION DATE: 23-SEP-2023. DEVICE MANUFACTURE DATE: 06-OCT-2022. MEDICAL DEVICE LOT#: 432122. MEDICAL DEVICE EXPIRATION DATE: 17-OCT-2023 DEVICE MANUFACTURE DATE: 01-NOV-2022.. HA DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6 INVESTIGATION SUMMARY: EVENT DESCRIPTION: " CUSTOMER COMPLAINTS ABOUT INCREASED CULTURE MEDIUM CONTAMINATION AFTER USING REF. 240862 KIT MYCOPREP 75 ML.¿ 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: THE REVIEW OF THE DEVICE HISTORY RECORD DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE NOTED. SAMPLE ANALYSIS: NO PHOTOS OR RETURNS WERE AVAILABLE. AN INSPECTION OF THE RETENTION SAMPLES WAS SATISFACTORY. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS AND THE RETENTION SAMPLES WERE SATISFACTORY. NO COMPLAINT TREND IS PRESENT ON THIS ISSUE WITH THIS PRODUCT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS NOT CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. HOWEVER, BD WILL CONTINUE TO MONITOR FOR TRENDING. H3 OTHER TEXT : SEE H.10.
THE FOLLOWING UPDATES HAVE BEEN MADE: THIS MDR PERTAINS ONLY TO LOT NUMBER 432122 B5. IT WAS REPORTED WHILE USING BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML, AN UNSPECIFIED QUANTITY OF THE CULTURE MEDIUM WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT. THIS RECORD IS BEING REOPENED TO ADDRESS THE CORRECTIONS REQUIRED FOR CAPA PR (B)(4).
THE FOLLOWING CORRECTION IS BEING MADE TO THE PREVIOUS MANUFACTURER NARRATIVE: THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
THE FOLLOWING FIELDS WERE CORRECTED: D2. MEDICAL DEVICE TYPE: PPM THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023¿2025, UNDER CAPA 11910483.
IT WAS REPORTED THAT BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML CONTAMINATION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS ABOUT INCREASED CULTURE MEDIUM CONTAMINATION AFTER USING REF. 240862 KIT MYCOPREP 75 ML. CUSTOMER HAS OBSERVED AN INCREASED RATE OF CULTURE CONTAMINATION (BOTH LIQUID AND SOLID, ESTIMATED FROM 3-4 % TO 10 %) AFTER INTRODUCING DECONTAMINATION WITH 240862 MYCOPREP 75 ML DUE TO LIMITED AVAILABILITY OF REGULAR KIT, 240863.
IT WAS REPORTED THAT BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML CONTAMINATION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS ABOUT INCREASED CULTURE MEDIUM CONTAMINATION AFTER USING REF. 240862 KIT MYCOPREP 75 ML. CUSTOMER HAS OBSERVED AN INCREASED RATE OF CULTURE CONTAMINATION (BOTH LIQUID AND SOLID, ESTIMATED FROM 3-4 % TO 10 %) AFTER INTRODUCING DECONTAMINATION WITH 240862 MYCOPREP 75 ML DUE TO LIMITED AVAILABILITY OF REGULAR KIT, 240863.
IT WAS REPORTED WHILE USING BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML, AN UNSPECIFIED QUANTITY OF THE CULTURE MEDIUM WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED WHILE USING BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML, AN UNSPECIFIED QUANTITY OF THE CULTURE MEDIUM WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
IT WAS REPORTED WHILE USING BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML, AN UNSPECIFIED QUANTITY OF THE CULTURE MEDIUM WAS CONTAMINATED. THERE WAS NO REPORT OF PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2189824 | BD MYCOPREP¿ SPECIMEN DIGESTION/DECONTAMINATION KIT, 75ML | REAGENT, GENERAL PURPOSE | PPM | BECTON, DICKINSON & CO. (SPARKS) | 432122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |