MAUDE Adverse Event Report: BAXTER HEALTHCARE - SWINFORD ENTERPRISE TSUNAGU SET CAP KIT; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number JPC4222

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a disconnect kit had been connected with no error, but there was a small gap under the cap.As a result, the next bag change was difficult, and the patient found it difficult to set the uv flash machine.The patient tried another disconnect kit from a different lot with no issues.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.

Manufacturer Narrative

(b)(4).The actual device was not available; however, a companion sample was received for evaluation.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed with no issues noted.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ENTERPRISE TSUNAGU SET CAP KIT
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - SWINFORD; foxford road; swinford ; EI
• Manufacturer (Section G): BAXTER HEALTHCARE - SWINFORD; foxford road; swinford ; EI
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5704483
• MDR Text Key: 46761964
• Report Number: 1416980-2016-10386
• 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: 06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: JPC4222
• Device Lot Number: 15F22H70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: No
• 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