MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-05-18 for BD BACTEC? 9050 BLOOD CULTURE SYSTEM manufactured by Becton, Dickinson & Co..
[45406014]
The bactec 9050 instrument is designed for the rapid detection of bacteria and fungi in clinical cultures of blood. Samples are drawn from patients and injected directly into bactec culture vials. Vials are then entered into the instrument as soon as possible to insure performance efficacy. The bactec 9050 systems users' manual provides detailed instructions for removing and replacing the rotor. Bd quality has evaluated the customer complaint for injury during maintenance and found no trends for this issue. Bd quality will continue to monitor. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[45406015]
Customer contacted bd technical service due to a grinding noise on their bd bactec 9050. The customer noted that while troubleshooting and removing the rotor she had injured her back. She sought medical attention at the er. She was prescribed medication and a shot but could not confirm what type of shot she received. She was also restricted until (b)(6) 2016 from lifting more than 10lbs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001119779-2016-00003 |
| MDR Report Key | 5663174 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-05-18 |
| Date of Report | 2016-05-18 |
| Date of Event | 2016-05-01 |
| Date Mfgr Received | 2016-05-01 |
| Date Added to Maude | 2016-05-18 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX CAROL NIETO |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| 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? 9050 BLOOD CULTURE SYSTEM |
| Generic Name | MONITOR, MICROBIAL GROWTH |
| Product Code | JTA |
| Date Received | 2016-05-18 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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. Required No Informationntervention | 2016-05-18 |