FDA Adverse Event
Malfunction
Summary report: N
IV CONNECT INV PLUS TOUCH SYST
MDR report key: 10178548
·
Received June 19, 2020
Report
- Report Number
- MW5095089
- Event Type
- Malfunction
- Date Received
- June 19, 2020
- Date of Event
- June 7, 2020
- Report Date
- June 9, 2020
- Manufacturer
- RYMED TECHNOLOGIES, LLC
- Product Code
- FPA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SPONTANEOUS CALL; PATIENT DID GO TO ER ON (B)(6) 2020, TRIED A COUPLE IV INVISION-PLUS CONNECTORS, LOT M01862 AND M01900 BOTH LEAKED. SHE WENT TO ER THINKING SOMETHING WAS WRONG WITH CENTRAL LINE, THEY JUST REPLACED CONNECTOR. RN BEING ASSIGNED TO SUGGEST ALTERNATIVE FOR RYMED INVISION PLUS CONNECTOR. ISSUES RESOLVED. NO INJURY AS RESULT. PHARMACY TO SHIP CONNECTOR BASED ON THE RECOMMENDATION FOR VELETRI INFUSION- WHICH IS LIFE SUSTAINING. CONNECTOR NOT AVAILABLE FOR RETURN, THEY WERE DISCARDED. NO FURTHER INFORMATION AVAILABLE. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636948 | IV CONNECT INV PLUS TOUCH SYST | SET, ADMINISTRATION, INTRAVASCULAR | FPA | RYMED TECHNOLOGIES, LLC | M01862 | ||
| 636949 | RYM 5000, INVISION PLUS CONNECTOR | SET, ADMINISTRATION, INTRAVASCULAR | FPA | RYMED TECHNOLOGIES, LLC | M01900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |