MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-12 for BD NEONATAL PROCEDURE TRAY UNKNOWN manufactured by Becton-dickinson..
[77314928]
Patient Sequence No: 1, Text Type: N, H10
[77314929]
Picc broke off where cath inserts into oval disc. Picc was still in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6633420 |
| MDR Report Key | 6633420 |
| Date Received | 2017-06-12 |
| Date of Report | 2017-05-03 |
| Date of Event | 2009-08-05 |
| Report Date | 2009-09-09 |
| Date Reported to FDA | 2009-09-09 |
| Date Reported to Mfgr | 2009-09-09 |
| Date Added to Maude | 2017-06-12 |
| 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 |
| 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 | BD NEONATAL PROCEDURE TRAY |
| Generic Name | PICC LINE |
| Product Code | OXQ |
| Date Received | 2017-06-12 |
| Model Number | UNKNOWN |
| Lot Number | 8231654 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON-DICKINSON. |
| Manufacturer Address | 9450 SOUTH STATE STREET SANDY UT 84070 US 84070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-12 |