BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
Report
- Report Number
- 2647876-2022-00169
- Event Type
- Malfunction
- Date Received
- July 8, 2022
- Date of Event
- June 8, 2022
- Report Date
- July 27, 2022
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904422882
- PMA / PMN Number
- SEE H.10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL REPORTER PHONE #: (B)(6). PMA/510(K)# K970512, K970333. 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 UPDATED: B5. IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THEY SHOWED FALSE NEGATIVES FOR HIV. THIS IS A REPORT OF TWO OCCURRENCES. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE REPORTING A QUERY OR POTENTIALLY AN ISSUE IDENTIFIED WITH USE OF THE MYCO F LYTIC BOTTLE 442288 FOR A HIV POSITIVE PATIENT. ESSENTIALLY THE PATIENT SAMPLE HAD ONE BOTTLE REMOVED IN ERROR EARLIER THAN THE PROTOCOL (42 DAYS) AS NEGATIVE AND THE SECOND BOTTLE WAS THEN REMOVED @ 43.5 DAYS ALSO AS NEGATIVE. BECAUSE ONE BOTTLE HAD BEEN REMOVED EARLY THEY DID A TERMINAL AURAMINE TEST AND IT WAS POSITIVE. THEY SENT THE SAMPLES TO (B)(6) HOSPITAL AND WHILE INTERMITTENT FOR WHATEVER PRIMARY TEST METHOD USED I BELIEVE, (B)(6) EVENTUALLY REPORTED BOTH BOTTLES AS POSITIVE FOR MYCOBACTERIUM GENAVENSE (M. GENAVENSE). THE BOTTLES WERE LOADED IN MARCH SO THE BOTTLES WERE NOT EXPIRED AT THE TIME OF USE. H6. INVESTIGATION SUMMARY: CATALOG 442288. BATCH NO. 1188588 EXPIRED. CUSTOMER REPORTED A FALSE NEGATIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. UPON FURTHER EVALUATION IT WAS NOTICED THAT COMPLAINT RECEIVED WAS FROM A PRODUCT ALREADY EXPIRED. NO INVESTIGATION CAN BE CONDUCTED TO THE RETENTION SAMPLES SINCE ITS PAST ITS EXPIRY DATE. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED SINCE THE LOT IS EXPIRED, NONETHELESS BATCH HISTORY RECORDS ARE ALWAYS REVIEWED PRIOR TO PRODUCT RELEASE. PRODUCT INSERT WARNINGS AND PRECAUTIONS SECTIONS STATES THAT PRIOR TO USE, EACH VIAL SHOULD BE EXAMINED FOR EVIDENCE OF CONTAMINATION SUCH AS CLOUDINESS, BULGING OR DEPRESSES SEPTUM, OR LEAKAGE. VIALS SHOWING EVIDENCE OF CONTAMINATION SHOULD NOT BE USED. ALSO PRIOR TO USE, THE USER SHOULD EXAMINE THE VIAL FOR EVIDENCE OF DAMAGE OR DETERIORATION. VIALS DISPLAYING TURBIDITY, CONTAMINATION, OR DISCOLORATION (DARKENING) SHOULD NOT BE USED. THE SPECIMEN MUST BE COLLECTED USING STERILE TECHNIQUES TO REDUCE THE CHANCE OF CONTAMINATION. QUALITY CONTROL REQUIREMENTS MUST BE PERFORMED IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND/OR FEDERAL REGULATIONS OR ACCREDITATION REQUIREMENTS AND LABORATORY¿S STANDARD QUALITY CONTROL PROCEDURES. IT IS RECOMMENDED THAT THE USER REFER TO PERTINENT CLSI GUIDANCE AND CLIA REGULATIONS FOR APPROPRIATE QUALITY CONTROL PRACTICES. DO NOT USE CULTURE VIALS PAST THEIR EXPIRATION DATE. DO NOT USE CULTURE VIALS THAT EXHIBIT ANY CRACKS OR DEFECTS; DISCARD THE VIAL IN THE APPROPRIATE MANNER. THE PLOTS DID NOT SHOW ANY UNUSUAL CHARACTERISTICS OR INDICATE A PROBLEM WITH THE MEDIA OR INSTRUMENT. COMPLAINT IS UNCONFIRMED. NO CORRECTIVE ACTIONS WERE REQUIRED. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS.
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THEY SHOWED FALSE NEGATIVES FOR HIV. THIS IS A REPORT OF TWO OCCURRENCES. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE REPORTING A QUERY OR POTENTIALLY AN ISSUE IDENTIFIED WITH USE OF THE MYCO F LYTIC BOTTLE 442288 FOR A HIV POSITIVE PATIENT. ESSENTIALLY THE PATIENT SAMPLE HAD ONE BOTTLE REMOVED IN ERROR EARLIER THAN THE PROTOCOL (42 DAYS) AS NEGATIVE AND THE SECOND BOTTLE WAS THEN REMOVED @ 43.5 DAYS ALSO AS NEGATIVE. BECAUSE ONE BOTTLE HAD BEEN REMOVED EARLY THEY DID A TERMINAL AURAMINE TEST AND IT WAS POSITIVE. THEY SENT THE SAMPLES TO ST. JAMES HOSPITAL DUBLIN AND WHILE INTERMITTENT FOR WHATEVER PRIMARY TEST METHOD USED I BELIEVE, ST. JAMES EVENTUALLY REPORTED BOTH BOTTLES AS POSITIVE FOR MYCOBACTERIUM GENAVENSE (M. GENAVENSE).
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS THEY SHOWED FALSE NEGATIVES FOR HIV. THIS IS A REPORT OF TWO OCCURRENCES. NO FALSE RESULTS WERE REPORTED OUT TO THE CLINICIAN OR THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE REPORTING A QUERY OR POTENTIALLY AN ISSUE IDENTIFIED WITH USE OF THE MYCO F LYTIC BOTTLE 442288 FOR A HIV POSITIVE PATIENT. ESSENTIALLY THE PATIENT SAMPLE HAD ONE BOTTLE REMOVED IN ERROR EARLIER THAN THE PROTOCOL (42 DAYS) AS NEGATIVE AND THE SECOND BOTTLE WAS THEN REMOVED @ 43.5 DAYS ALSO AS NEGATIVE. BECAUSE ONE BOTTLE HAD BEEN REMOVED EARLY THEY DID A TERMINAL AURAMINE TEST AND IT WAS POSITIVE. THEY SENT THE SAMPLES TO (B)(6) HOSPITAL AND WHILE INTERMITTENT FOR WHATEVER PRIMARY TEST METHOD USED I BELIEVE, (B)(6) EVENTUALLY REPORTED BOTH BOTTLES AS POSITIVE FOR MYCOBACTERIUM GENAVENSE (M. GENAVENSE). THE BOTTLES WERE LOADED IN MARCH SO THE BOTTLES WERE NOT EXPIRED AT THE TIME OF USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2103351 | BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 1188588 | 00382904422882 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |