MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-01 for BBL SEPTI-CHEK TSB * B1096-24 [4371580] manufactured by Becton Dickinson Microbiology Systems.
[85858]
Old vacutainer blood culture bottles are no longer available from co. Only septi check bottles (for blood cultures) are available. The old, safe venting unit does not fit the septi-check bottle. New venting units without protective shields must be used. It is almost impossible to remove venting units from bottles for proper disposal (& if they could be removed, no protective shield would cover the "sharp" end).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013708 |
| MDR Report Key | 165710 |
| Date Received | 1998-05-01 |
| Date of Report | 1998-04-29 |
| Date of Event | 1998-04-14 |
| Date Added to Maude | 1998-05-06 |
| 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 |
| 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 | BBL SEPTI-CHEK TSB |
| Generic Name | BLOOD CULTURE BOTTLE (PEDIATRIC) 10 X 20 ML |
| Product Code | JSL |
| Date Received | 1998-05-01 |
| Model Number | * |
| Catalog Number | B1096-24 [4371580] |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 161260 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | 7 LOVETON CIR. SPARKS MD 211520999 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-05-01 |