MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-08 for BAC T ALERT AEROBIC CURO BOTTLE manufactured by Organon Teknika Corp..
[17703]
Rn drew 1 cc of blood for blood culture. Changed needles to ensure sterile entry into culture tube. Expelled. 5 cc of blood into culture vial, then pressure from tube caused needle to detach from syringe causing blood to splatter over rn, countertops and pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008300 |
| MDR Report Key | 29974 |
| Date Received | 1996-02-08 |
| Date of Report | 1996-02-07 |
| Date of Event | 1996-02-03 |
| Date Added to Maude | 1996-02-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAC T ALERT AEROBIC CURO BOTTLE |
| Generic Name | SPECIMEN TUBE |
| Product Code | JSC |
| Date Received | 1996-02-08 |
| Lot Number | 104647 |
| Device Expiration Date | 1996-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31067 |
| Manufacturer | ORGANON TEKNIKA CORP. |
| Manufacturer Address | 100 AKZO AVE DURHAM NC 27704 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-02-08 |