MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for LUMBAR PUNCTURE TRAY 4301C manufactured by Carefusion 2200, Inc.
[138658663]
Lumbar puncture trays opened x 2 and both found to have debris on the collection tubes. Manufacturer response for adult lumbar puncture tray, adult lumbar puncture tray (per site reporter). Equipment failure called to bd representative. Arrangements made to return involved equipment to bd. (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8416013 |
| MDR Report Key | 8416013 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-01-31 |
| Report Date | 2019-02-28 |
| Date Reported to FDA | 2019-02-28 |
| Date Reported to Mfgr | 2019-03-13 |
| Date Added to Maude | 2019-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LUMBAR PUNCTURE TRAY |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-02-28 |
| Model Number | 4301C |
| Catalog Number | 4301C |
| Lot Number | 001265024 |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-13 |