MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS manufactured by Medisystems Corp..
[111197867]
Arterial hemodialysis fistula needle set had a hole in the tubing. This caused air to be sucked into the extracorporeal circuit. There was also leak of pt's blood through the hole to the exterior, and a direct path for potential organisms to enter the bloodstream. Dates of use: (b)(6) 2018. Diagnosis or reason for use: hemodialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077849 |
| MDR Report Key | 7600602 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-06-11 |
| Date Added to Maude | 2018-06-14 |
| 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 | OTHER CAREGIVERS |
| 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 | TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS |
| Generic Name | 16G FISTULA NEEDLE |
| Product Code | FIE |
| Date Received | 2018-06-13 |
| Lot Number | 180223F2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDISYSTEMS CORP. |
| Manufacturer Address | 350 MERRIMACK STREET LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-06-13 |