MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 10F X 24CM SPLIT CATH SET; SPLIT CATH III LT HEMODIALYSIS CATHETER

Model Number	DASPC24P-XL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Upon inspection of the patient's implanted catheter, it was noted that one of the lumens was partially disassociated from its hub.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation and no photographs were provided.Multiple requests for additional information and clarification of event were unsuccessful.The exact location of the partial dissociation was not provided.The contract manufacturer conducted a review of the manufacturer records for the lot number reported.The device history record review showed nothing out of specification, no authorized manufacture variance, non-conformance report, or reworks related to the reported failure mode.The lot was manufactured according to specifications.Without sufficient information and an evaluation of the device involved we are unable to determine the cause or factors that may have contributed to this event.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 10F X 24CM SPLIT CATH SET
• Common Device Name: SPLIT CATH III LT HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 16139224
• Report Number: 2518902-2023-00005
• Device Sequence Number: 6717752
• Product Code: MSD
• UDI-Device Identifier: 00884908150506
• UDI-Public: 00884908150506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/07/2024
• Device Model Number: DASPC24P-XL
• Device Catalogue Number: DASPC24P-XL
• Device Lot Number: MPSK030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 48 KG