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

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).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a small gap between the transfer set and the disconnect cap.There was patient involvement.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 device was received for sample evaluation.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 issue was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 5704529
• MDR Text Key: 46761905
• Report Number: 1416980-2016-10388
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

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: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2016
• 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