MAUDE Adverse Event Report: KANAE CO.,LTD. LOCKING TITANIUM ADAPTER; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number ATC4510

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.Same event as (b)(4).

Event Description

It was reported that a titanium adaptor had a poor connection with a patient adaptor of a transfer set.The reporter stated that there was a gap between the two components.This was noticed while the transfer set was being changed in the hospital.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and an evaluation is complete.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Connection test and dimensional inspection were performed with no issues noted.The device was within specifications and the reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LOCKING TITANIUM ADAPTER
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): KANAE CO.,LTD.; 4-11-5, haccyoubori, chuo-ku,; JA
• Manufacturer (Section G): KANAE CO.,LTD.; 4-11-5, haccyoubori, chuo-ku; JA
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5267336
• MDR Text Key: 32683222
• Report Number: 1416980-2015-43360
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ATC4510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1