FDA Adverse Event
Malfunction
Summary report: N
JONES TUBE
MDR report key: 10250065
·
Received July 8, 2020
Report
- Report Number
- MW5095429
- Event Type
- Malfunction
- Date Received
- July 8, 2020
- Date of Event
- June 16, 2020
- Report Date
- July 6, 2020
- Manufacturer
- GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC.
- Product Code
- HNL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE PLACING A 4 X 16 JONES TUBE DURING A BILATERAL DACRYOCYSTORHINOSTOMY JONES TUBES CONJUNCTIVORHINOSTOMY PLACEMENT TUBE HAD BROKEN AND A PIECE OF THE JONES TUBE (GLASS) THOUGHT TO BE IN OR AROUND THE PATIENT. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712848 | JONES TUBE | PROBE, LACHRYMA | HNL | GUNTHER WEISS SCIENTIFIC GLASSBLOWING CO., INC. | 3005489143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |