FDA Adverse Event
Malfunction
Summary report: N
ENDOINK
MDR report key: 14955710
·
Received July 8, 2022
Report
- Report Number
- 14955710
- Event Type
- Malfunction
- Date Received
- July 8, 2022
- Date of Event
- April 11, 2022
- Report Date
- June 22, 2022
- Manufacturer
- MICRO-TECH (NAN JING) CO., LTD.
- Product Code
- NBG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ENDOINK LUER CAP WOULD NOT STAY ATTACHED TO SYRINGE. NEW DEVICE OBTAINED AND CASE CONTINUED WITHOUT INCIDENT. UNFORTUNATELY, DEVICE AND PACKAGING DISCARDED DURING CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1986306 | ENDOINK | MARKER, COLON | NBG | MICRO-TECH (NAN JING) CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18980 DA | Unknown |