MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-03 for WHIN SAFETY HUBER NEEDLE 571114 manufactured by Bard.
[88159157]
Patient uses the whin 22 g1" safety huber to access his port daily. Developed a tear in his port site that went all the way to the implanted septum, from needle movement. Port had to be surgically removed and a new port implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072568 |
| MDR Report Key | 6910880 |
| Date Received | 2017-10-03 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-13 |
| Date Added to Maude | 2017-10-03 |
| 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 | WHIN SAFETY HUBER NEEDLE |
| Generic Name | HUBER NEEDLE |
| Product Code | PTI |
| Date Received | 2017-10-03 |
| Model Number | 571114 |
| Lot Number | REB52693 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD |
| Manufacturer Address | SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-10-03 |