MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-18 for MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET WITH MASTERGUARD S9-7005MGLB manufactured by Medisystems Corporation (a Nxstage Company).
[73074600]
The device was not returned for investigation. No related defects were noted upon review of the retention sample. The device history record (dhr) indicated the product was released having met all specification and no defects were noted during the manufacturing process. Though requested, no information was provided regarding treatment or outcome of the user related to the needlestick. Nxstage medical considers this report closed. No additional information will be provided.
Patient Sequence No: 1, Text Type: N, H10
[73074601]
A report was received on march 22, 2017 regarding a user facility employee who experienced a needlestick on (b)(6) 2017 when removing the treatment needle from the arteriovenous fistula (avf). There was no adverse impact to the involved patient. User facility protocol was followed for the employee and although requested additional information is not available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2919260-2017-00002 |
| MDR Report Key | 6501353 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-18 |
| Date of Report | 2017-04-18 |
| Date of Event | 2017-03-13 |
| Date Mfgr Received | 2017-03-22 |
| Device Manufacturer Date | 2016-11-11 |
| Date Added to Maude | 2017-04-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. PAULA ROGALSKI |
| Manufacturer Street | NXSTAGE MEDICAL, INC 350 MERRIMACK STREET |
| Manufacturer City | LAWRENCE MA 01843 |
| Manufacturer Country | US |
| Manufacturer Postal | 01843 |
| Manufacturer Phone | 9786874700 |
| Manufacturer G1 | KAWASUMI LABORATORIES (THAILAND) CO., LTD. |
| Manufacturer Street | 48 MU8, RATCHASIMA CHOKCHAI RO TAMBON THA ANG |
| Manufacturer City | NAKHON RATCHASIMA 30190 |
| Manufacturer Country | TH |
| Manufacturer Postal Code | 30190 |
| 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 | 2017-04-18 |
| Model Number | S9-7005MGLB |
| Catalog Number | S9-7005MGLB |
| Lot Number | 161122F2 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDISYSTEMS CORPORATION (A NXSTAGE COMPANY) |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-18 |