FDA Adverse Event
Malfunction
Summary report: N
INVISION-PLUS
MDR report key: 15014348
·
Received July 14, 2022
Report
- Report Number
- 3005951712-2016-00021
- Event Type
- Malfunction
- Date Received
- July 14, 2022
- Date of Event
- March 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 RN WAS INITIALLY FLUSHING THE CAP, THE CAP FELL APART. DID NOT REACHED THE PATIENT. 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 ADDITIONAL DETAILS SURROUNDING THE INCIDENT ARE AVAILABLE. (B)(4). THIS REPORT IS A POST INSPECTION RETROSPECTIVE REVIEW. 2016 INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469293 | INVISION-PLUS | NEEDLELESS IV CONNECTOR | FPA | RYMED TECHNOLOGIES, LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |