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

Catalog Number ASKU

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that a minicap would not tighten on the female connector of a transfer set.This was observed after draining the patient and placing a cap on transfer set.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The event occurred on an unspecified date, over the past weekend from the report date.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual sample was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected and no visible defects on the minicap were observed.A visible damage to the transfer set was observed.The reported condition was not verified.The most likely cause of the reported connection issue was related to the transfer set and not the minicap.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15531556
• MDR Text Key: 306166386
• Report Number: 1416980-2022-05253
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2023

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: Other
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/04/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: MINICAP TRANSFER SET