BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2023-00225
- Event Type
- Malfunction
- Date Received
- October 5, 2023
- Date of Event
- August 30, 2023
- Report Date
- November 27, 2023
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420239
- PMA / PMN Number
- K113558
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: CUSTOMER REPORTED A MOLECULAR FALSE POSITIVE RESULT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE THE CUSTOMER¿S EXPERIENCE WITH THE BACTEC PRODUCT BASED ON OUR INTERNAL PROCEDURES AND THE INTENDED USE OF THE PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED, TESTED FOR VIABLE CONTAMINATION BY SUB-CULTURING ON TSA, CHOCOLATE, SABOURAUD AND SCHAEDLER AGARS PLATES, VOLTAGE OUTPUT AND GRAM STAIN. ALL RESULTS WERE SATISFACTORY. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED, AND BATCH HAS BEEN PREVIOUSLY INVESTIGATED FOR THE REPORTED DEFECT. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B3: DATE OF EVENT: UPDATED TO 30-AUG-2023.
G.5. PMA / 510(K)#: K222591. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE OF A PATIENT SAMPLE. NO REPORT OF ADVERSE EVENTS OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FX 442023_3102712 - MOLECULAR FP. 1 MOLECULAR FP. TESTED ON BCID2, LOT # 1191323. BIOFIRE WAS A DUAL POSITIVE - PS. AERUGINOSA AND C. TROPICALIS. CULTURE GREW PS. AERUGINOSA. GRAM STAIN WAS GRAM NEGATIVE RODS. RESULT WAS NOT REPORTED TO PHYSICIAN AND THERE WAS NO TREATMENT CHANGE."
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE OF A PATIENT SAMPLE. NO REPORT OF ADVERSE EVENTS OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FX 442023_3102712 - MOLECULAR FP. 1 MOLECULAR FP. TESTED ON BCID2, LOT # 1191323. BIOFIRE WAS A DUAL POSITIVE - PS. AERUGINOSA AND C. TROPICALIS. CULTURE GREW PS. AERUGINOSA. GRAM STAIN WAS GRAM NEGATIVE RODS. RESULT WAS NOT REPORTED TO PHYSICIAN AND THERE WAS NO TREATMENT CHANGE."
IT WAS REPORTED THAT WHILE USING BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC), THERE WAS 1 MOLECULAR FALSE POSITIVE OF A PATIENT SAMPLE. NO REPORT OF ADVERSE EVENTS OR INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FX 442023_3102712 - MOLECULAR FP. 1 MOLECULAR FP. TESTED ON BCID2, LOT # 1191323 . BIOFIRE WAS A DUAL POSITIVE - PS. AERUGINOSA AND C. TROPICALIS. CULTURE GREW PS. AERUGINOSA. GRAM STAIN WAS GRAM NEGATIVE RODS. RESULT WAS NOT REPORTED TO PHYSICIAN AND THERE WAS NO TREATMENT CHANGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2096082 | BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 3102712 | 00382904420239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |