BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
Report
- Report Number
- 2647876-2025-00001
- Event Type
- Injury
- Date Received
- January 9, 2025
- Date of Event
- December 10, 2024
- Report Date
- March 28, 2025
- Manufacturer
- BECTON DICKINSON CARIBE LTD.
- Product Code
- MDB
- UDI-DI
- 00382904420208
- PMA / PMN Number
- K151866
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
E.1: INITIAL REPORTER ADDR 1: (B)(6). THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K173873 A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 2647876-2025-00001 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
INVESTIGATION SUMMARY - CATALOG 442020. BATCH NO. 4136597. CUSTOMER REPORTED A FALSE POSITIVE DEFECT. NEITHER PHOTOS NOR RETURNED GOOD SAMPLES WERE RECEIVED. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH THE BACTEC PRODUCT. A FALSE POSITIVE RESPONSE WAS NOT OBSERVED WHEN RETENTION SAMPLES WERE TESTED. BATCH HISTORY RECORDS WERE REVIEWED, AND ALL TESTING WERE WITHIN SPECIFICATION FOR PRODUCT RELEASE. 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. THERE IS NO FALSE POSITIVE ROOT CAUSE ASSOCIATED WITH PLOTS RECEIVED. COMPLAINT IS UNCONFIRMED BASED ON RETENTION SAMPLES AND BATCH HISTORY RECORD REVIEW RESULTS. NO CORRECTIVES 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 INVESTIGATION PROCESS.
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE POSITIVE PATIENT RESULT. THE PATIENT WAS INITIALLY BEING TREATED WITH CEFEPIME AND VANCOMYCIN. HOWEVER, BASED ON THE RESULTS, VANCOMYCIN WAS DISCONTINUED, AND CEFEPIME COVERAGE WAS EXTENDED. AFTER THE CORRECTED RESULTS WERE RECEIVED, CEFEPIME WAS ALSO DISCONTINUED. NO ADVERSE IMPACT WAS REPORTED AS A RESULT OF THE TREATMENT CHANGE.
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE POSITIVE PATIENT RESULT. THE PATIENT WAS INITIALLY BEING TREATED WITH CEFEPIME AND VANCOMYCIN. HOWEVER, BASED ON THE RESULTS, VANCOMYCIN WAS DISCONTINUED, AND CEFEPIME COVERAGE WAS EXTENDED. AFTER THE CORRECTED RESULTS WERE RECEIVED, CEFEPIME WAS ALSO DISCONTINUED. NO ADVERSE IMPACT WAS REPORTED AS A RESULT OF THE TREATMENT CHANGE.
IT WAS REPORTED WHILE USING BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) THERE WAS ONE FALSE POSITIVE PATIENT RESULT. THE PATIENT WAS INITIALLY BEING TREATED WITH CEFEPIME AND VANCOMYCIN. HOWEVER, BASED ON THE RESULTS, VANCOMYCIN WAS DISCONTINUED, AND CEFEPIME COVERAGE WAS EXTENDED. AFTER THE CORRECTED RESULTS WERE RECEIVED, CEFEPIME WAS ALSO DISCONTINUED. NO ADVERSE IMPACT WAS REPORTED AS A RESULT OF THE TREATMENT CHANGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1169422 | BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC) | SYSTEM, BLOOD CULTURING | MDB | BECTON DICKINSON CARIBE LTD. | 4136597 | 00382904420208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |