MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-09 for ADULT LUMBAR PUNCTURE TRAY 4301C manufactured by Carefusion/ Bd.
[67340757]
The catheter provided with a lumbar puncture kit leaks and the whole batch is bad, multiple kits leak. Multiple lot numbers are defective. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067829 |
| MDR Report Key | 6325466 |
| Date Received | 2017-02-09 |
| Date of Report | 2017-02-09 |
| Date of Event | 2017-02-08 |
| Date Added to Maude | 2017-02-13 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ADULT LUMBAR PUNCTURE TRAY |
| Generic Name | LUMBAR PUNCTURE TRAY |
| Product Code | FCH |
| Date Received | 2017-02-09 |
| Catalog Number | 4301C |
| Lot Number | 0001003160 |
| Device Expiration Date | 2019-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION/ BD |
| Manufacturer Address | NEW HAVEN CT 06510 US 06510 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-09 |