MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-04-04 for PEDIATRIC/INFANT LUMBAR PUNCTURE TRAY * 4304C manufactured by Carefusion 2200, Inc..
[4419387]
When the provider opened the sterile lumbar puncture tray, a long dark hair was observed under the sterile wrappings on top of the sterile trocar. As it was noted prior to the procedure, none of the items were removed from the packaging and the entire tray was taken from the room and replaced with a new set up for the procedure. ======================manufacturer response for pediatric/infant lumbar puncture tray, carefusion pediatric/infant lumbar puncture tray (per site reporter). ======================director materials management contacted sales rep immediately with information as have had several problems with sterile trays.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3758554 |
| MDR Report Key | 3758554 |
| Date Received | 2014-04-04 |
| Date of Report | 2014-04-04 |
| Date of Event | 2014-01-28 |
| Report Date | 2014-04-04 |
| Date Reported to FDA | 2014-04-04 |
| Date Reported to Mfgr | 2014-04-18 |
| Date Added to Maude | 2014-04-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEDIATRIC/INFANT LUMBAR PUNCTURE TRAY |
| Generic Name | NEUROLOGICAL TRAY |
| Product Code | OJG |
| Date Received | 2014-04-04 |
| Model Number | * |
| Catalog Number | 4304C |
| Lot Number | 0000556154 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-04 |