MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET WITH MASTERGUARD S9-4005MG manufactured by Medisystems Corporation.
[97124000]
Patient Sequence No: 1, Text Type: N, H10
[97124001]
During patient cannulation, the caregiver noticed a "red ring" at the end cap. The thought of potential contamination with red colored substance in fistula line at the cap, the needle was withdrawn and different lot used with desired results. The lot numbers involved have been taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7185564 |
| MDR Report Key | 7185564 |
| Date Received | 2018-01-12 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-12-09 |
| Report Date | 2017-12-11 |
| Date Reported to FDA | 2017-12-11 |
| Date Reported to Mfgr | 2017-12-11 |
| Date Added to Maude | 2018-01-12 |
| 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 | MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET WITH MASTERGUARD |
| Generic Name | NEEDLE, FISTULA |
| Product Code | FIE |
| Date Received | 2018-01-12 |
| Model Number | S9-4005MG |
| Catalog Number | S9-4005MG |
| Lot Number | 170511F2, 170609F1 |
| ID Number | 15 GAUGE |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDISYSTEMS CORPORATION |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |