MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LOCKING TITANIUM ADPATER; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number ATC4510

Device Problems Loose or Intermittent Connection (1371); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a connection issue between the transfer set spike and the titanium adapter.It was further reported that the connection between the transfer set spike and the titanium adapter ¿were loose and couldn't connect.This occurred during use of peritoneal dialysis therapy.The titanium adapter was replaced.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional inforamtion: h6.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LOCKING TITANIUM ADPATER
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11065238
• MDR Text Key: 223599737
• Report Number: 1416980-2020-08007
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ATC4510
• Device Lot Number: K18121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/28/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSFER SET