BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT
Report
- Report Number
- 1119779-2024-00142
- Event Type
- Malfunction
- Date Received
- February 23, 2024
- Date of Event
- January 26, 2024
- Report Date
- September 13, 2024
- Manufacturer
- BECTON DICKINSON & CO. (SPARKS)
- Product Code
- MDB
- UDI-DI
- 00382902451242
- PMA / PMN Number
- K954932
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. E.1 INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. G.5. PMA / 510(K)#: K974883. H.3. A DEVICE EVALUATION AND OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE CORRECTED: D4. MEDICAL DEVICE LOT #: INVALID BATCH TO UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: BLANK TO UNKNOWN. H4. DEVICE MANUFACTURE DATE: BLANK TO UNKNOWN. ANNEX B: BLANK TO B21. ANNEX C: BLANK TO C21. ANNEX D: BLANK TO D16.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B5 DESCRIBE EVENT: IT WAS REPORTED THAT PRIOR TO USE OF BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, LYOPHILIZED, IT WAS NOTICED THAT THERE WAS A CONTAMINANT IN THE MEDIA. NO PATIENT IMPACT REPORTED. D4 MEDICAL DEVICE BRAND NAME: BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT D4 MEDICAL DEVICE CATALOG #: 245124 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). INVESTIGATION SUMMARY: MGIT PANTA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER SOP. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). PANTA BATCH NUMBER 2322153 WAS PROVIDED BY THE CUSTOMER. BATCH HISTORY REVIEW FOR PANTA BATCH 2322153 WAS SATISFACTORY PER INTERNAL PROCEDURES. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. FOR THIS PRODUCT, RETENTION SAMPLES ARE MAINTAINED AS INDIVIDUAL COMPONENTS AND NO COMPLETE CARTONS WERE AVAILABLE FOR INSPECTION. THE COMPLAINT HISTORY WAS REVIEWED AND THERE ARE NO OTHER COMPLAINTS ON THE COMPONENT OF THIS KIT. THERE WERE NINE RETENTION SAMPLES FOR PANTA BATCH 2322153. FOUR PANTA VIALS WERE RECONSTITUTED WITH 15ML AUTOCLAVED WATER. THE APPEARANCE OF THE RECONSTITUTED PANTA WAS TRACE HAZY AND PALE YELLOW. FOR FURTHER INVESTIGATION TWO RECONSTITUTED PANTA VIALS FROM BATCH 2322153 WERE PLACED INTO 20-25-DEGREES CELSIUS INCUBATOR AND TWO RECONSTITUTED PANTA VIALS FROM BATCH 2322153 WERE PLACED INTO 33-37-DEGREES CELSIUS INCUBATOR. AT SEVEN DAYS INCUBATION, NO GROWTH WAS OBSERVED IN THE INCUBATED RETENTION VIALS. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. ONE PHOTO SHOWED ONE RECONSTITUTED PANTA VIAL WITH SOME GROWTH FLOATING IN SOLUTION. ONE PHOTO SHOWED ONE VIAL OF PANTA 2322153. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. WITHOUT THE KIT BATCH NUMBER OR SUPPLEMENT BATCH NUMBER ASSOCIATED WITH THIS KIT, THE COMPONENTS OF THIS KIT CANNOT BE VERIFIED. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION.
IT WAS REPORTED THAT PRIOR TO USE OF BD BBL¿ MGIT¿ PANTA¿ ANTIBIOTIC MIXTURE, LYOPHILIZED, IT WAS NOTICED THAT THERE WAS A CONTAMINANT IN THE MEDIA. NO PATIENT IMPACT REPORTED.
IT WAS REPORTED THAT PRIOR TO USE OF BD BBL¿ MGIT¿ PANTA¿ ANTIBIOTIC MIXTURE, LYOPHILIZED, IT WAS NOTICED THAT THERE WAS A CONTAMINANT IN THE MEDIA. NO PATIENT IMPACT REPORTED.
IT WAS REPORTED THAT PRIOR TO USE OF BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT, LYOPHILIZED, IT WAS NOTICED THAT THERE WAS A CONTAMINANT IN THE MEDIA. NO PATIENT IMPACT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228429 | BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON & CO. (SPARKS) | UNKNOWN | 00382902451242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |