MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for POWERPICC SOLO manufactured by Medline Industries.
[139752072]
Retention of picc styler tip after insertion of picc line. There was no resistance or issues with placement of the picc line. Our picc team found 3 reports on the fda website of this picc stylet breaking either in the pt or after use. The stylet fragment was unable to be retrieved from the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085109 |
| MDR Report Key | 8448205 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-01-14 |
| Date Added to Maude | 2019-03-25 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | POWERPICC SOLO |
| Generic Name | CENTRAL VENOUS CATHETER TRAY |
| Product Code | OFF |
| Date Received | 2019-03-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Brand Name | BARD MYPICC KIT |
| Generic Name | CATHETER INTRAVASCULAR THERAPEUTIC LONG TERM |
| Product Code | LJS |
| Date Received | 2019-03-22 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-22 |