FDA Adverse Event
Malfunction
Summary report: N
LOCKING TITANIUM ADAPTER
MDR report key: 3140967
·
Received June 3, 2013
Report
- Report Number
- 1416980-2013-13984
- Event Type
- Malfunction
- Date Received
- June 3, 2013
- Date of Event
- May 8, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL OR RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S TITANIUM ADAPTER WAS NOT CONNECTING WELL TO THE PATIENT CONNECTOR. A GAP WAS OBSERVED IN THE JUNCTION BETWEEN THE ADAPTER AND THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 244151 | LOCKING TITANIUM ADAPTER | SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE. | KDJ | KANAE CO.,LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TRANSFER SET |