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

Catalog Number	5C4129
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The first affiliated hospital of (b)(6).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.
Event or Problem Description
It was reported that the titanium adapter packaging was opened.This was observed prior to use of the device for peritoneal dialysis therapy.There was no patient involvement.No additional information is available.

• Brand Name: LOCKING TITANIUM ADAPTER
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12294433
• Report Number: 1416980-2021-04878
• Device Sequence Number: 3130682
• Product Code: KDJ
• UDI-Device Identifier: 00085412007403
• UDI-Public: (01)00085412007403
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K152675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 5C4129
• Device Lot Number: 17K07H35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1