FDA Adverse Event
Malfunction
Summary report: N
LOCKING TITANIUM ADAPTER
MDR report key: 3140879
·
Received June 3, 2013
Report
- Report Number
- 1416980-2013-13978
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 4, 2013
- Report Date
- May 8, 2013
- Manufacturer
- KANAE CO.,LTD.
- Product Code
- KDJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. THEREFORE, NO ANALYSIS CAN BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A TITANIUM ADAPTER HAD A CONNECTION ISSUE DURING PATIENT USE. THE PATIENT CONNECTOR HAD NOT CONNECTED WITH THE TITANIUM ADAPTER WHEN THE TRANSFER SET WAS CHANGED. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE EVENT WAS INDICATED AT THE TIME OF THE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245347 | LOCKING TITANIUM ADAPTER | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE. | KDJ | KANAE CO.,LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TRANSFER SET |