FDA Adverse Event
Malfunction
Summary report: N
INVISION-PLUS
MDR report key: 15014530
·
Received July 14, 2022
Report
- Report Number
- 3005951712-2016-00024
- Event Type
- Malfunction
- Date Received
- July 14, 2022
- Date of Event
- April 1, 2016
- Report Date
- July 14, 2022
- Manufacturer
- RYMED TECHNOLOGIES, LLC
- Product Code
- FPA
- PMA / PMN Number
- K991653
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS A POST INSPECTION RETROSPECTIVE REVIEW. 2016 INCIDENT.
Description of Event or Problem · 0
ON (B)(6) 2016 THE DISTRIBUTOR REPORTED TO RYMED THAT THEY HAD RECEIVED NOTIFICATION THAT THEIR CUSTOMER HAD EXPERIENCED AN ISSUE WITH THE PRODUCT. REPORTED THAT WHEN THE NURSE ATTEMPTED TO ATTACH SYRINGE FOR INITIAL FLUSH, THE PLASTIC HOUSING CAME APART ON THE VALVE. NO PATIENT INJURY; NEVER REACHED THE PATIENT. 1 SAMPLE WAS RECEIVED (B)(6) 2016 IT WAS CONFIRMED THAT THERE WAS 1 INCIDENT WHERE THE CONNECTOR SEPARATED PRIOR TO USE. NO DETAILS SURROUNDING THE INCIDENT ARE AVAILABLE. REPORTED AS PRODUCT CODE 460207, LOT UNKNOWN. THIS REPORT IS A POST INSPECTION RETROSPECTIVE REVIEW. 2016 INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1955363 | INVISION-PLUS | NEEDLELESS IV CONNECTOR | FPA | RYMED TECHNOLOGIES, LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |