FDA Adverse Event
Malfunction
Summary report: N
LACRICATH LACRIMAL DUCT CATHETER,2.0MM
MDR report key: 681389
·
Received February 7, 2006
Report
- Report Number
- 1649914-2006-00005
- Event Type
- Malfunction
- Date Received
- February 7, 2006
- Date of Event
- December 28, 2005
- Manufacturer
- QUEST MEDICAL, INC.
- Product Code
- HNW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A DCP PROCEDURE, THE BALLOON CATHETER WAS IN PLACE AND UPON INFLATION, IT WAS DISCOVERED THAT THE CATHETER WAS LEAKING FROM THE BALLOON END. ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY COMPLICATIONS. THE COMPLAINT SAMPLE WAS SAVED AND WILL BE RETURNED TO QUEST FOR EVALUATION. THE DEVICE IS PACKAGED IN A KIT. THE PART NUMBER OF THE KIT DCP213-BI, LOT 24837. THE PART NUMBER OF THE DEVICE THAT ALLEGEDLY FAILED IS LDC213, LOT 24592.05Y. THE MDR WILL BE FILED ON THE LDC213 CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LACRICATH LACRIMAL DUCT CATHETER,2.0MM | MANUAL OPHTHALMIC SURGICAL INSTRUMENT: LACRYMAL DILATOR | HNW | QUEST MEDICAL, INC. | LDC213 | 24592.05Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |