MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	5C4129
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a titanium adapter disconnected from the catheter; further described as "the titanium joint and catheter fell off." this was observed during use of the devices for peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event, however the patient was provided antibiotic treatment.No additional information is available.
Additional Manufacturer Narrative
D4: the lot number is unknown, therefore, only a primary di number could be provided.E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing including was performed and no issues were observed.The reported condition was not verified.Should additional relevant information become available a supplemental report will be submitted.

• Brand Name: LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SWINFORD; foxford road; swinford ; EI
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19972460
• Report Number: 1416980-2024-04221
• Device Sequence Number: 8387100
• Product Code: KDJ
• UDI-Device Identifier: 00085412007403
• UDI-Public: 00085412007403
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: Other
• Device Catalogue Number: 5C4129
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown