MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-02-26 for BD BACTEC? FX40 INSTRUMENT 442296 manufactured by Becton, Dickinson & Co..
[181087404]
Expiration date: unknown. The expiration date was not provided. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. While death was reported, there is no information provided that the patient? S death was caused or contributed by the device.
Patient Sequence No: 1, Text Type: N, H10
[181087405]
It was reported that a bd bactec? Fx40 instrument flagged a false negative for an aerobic bottle with the result being reported out after the patient expired. The patient was a referral to the hospital from a lower facility, and was unconscious reaching the hospital. The blood was drawn from the patient on the (b)(6) 2020 (aerobic and anaerobic). On the (b)(6) 2020, the anaerobic vial was flagged positive by the bd bactec? Fx40 instrument. The lab subcultured the blood, but results were not reported out. The aerobic bottle reached end of protocol on (b)(6) 2020 and when the lab followed up they learned the patient expired on (b)(6) 2020. The results were finalized on the (b)(6) 2020, positive for citrobacter freundii.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2020-00003 |
| MDR Report Key | 9758865 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-01-31 |
| Date Mfgr Received | 2020-02-05 |
| Device Manufacturer Date | 2017-10-16 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD BACTEC? FX40 INSTRUMENT |
| Generic Name | MICROBIAL GROWTH MONITOR |
| Product Code | MDB |
| Date Received | 2020-02-26 |
| Model Number | 442296 |
| Catalog Number | 442296 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-26 |