MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-06-21 for CAREFUSION 4302CSP manufactured by Carefusion.
[2113249]
Safe-t plus lumbar puncture trays - spinal needle with manometer pediatric/infant. Two trays missing parts for pressure gauge. Extension missing. No harm to pt. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021086 |
| MDR Report Key | 2139049 |
| Date Received | 2011-06-21 |
| Date of Report | 2011-06-20 |
| Date of Event | 2011-06-20 |
| Date Added to Maude | 2011-06-29 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAREFUSION |
| Generic Name | SAFE-T PLUS LUMBAR PUNCTURE TRAY |
| Product Code | OJG |
| Date Received | 2011-06-21 |
| Catalog Number | 4302CSP |
| Lot Number | L1C374 |
| Device Expiration Date | 2013-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-21 |