MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F X 18CM SILICONE HEMO-CATH; HEMO-CATH LT

Model Number	DSL18P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.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
Catheter found to allow blood infused in one lumen to flow through the other lumen.This resulted in recirculation of dialysate and inadequate dialysis.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.Additional information and clarification was requested but not provided.The contract manufacturer conducted a review of the manufacture records for the lot number provided.A record review of the device lot numbers showed no nonconformities or other abnormalities.There were no deviations or process changes in the manufacturing and/or materials with the part numbers.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have revealed this type of failure if it had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.

• Brand Name: 8F X 18CM SILICONE HEMO-CATH
• Common Device Name: HEMO-CATH LT
• 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: 15186652
• Report Number: 2518902-2022-00049
• Device Sequence Number: 20295547
• Product Code: MSD
• UDI-Device Identifier: 00884908144895
• UDI-Public: 884908144895
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K893439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2022

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: 01/05/2025
• Device Model Number: DSL18P
• Device Catalogue Number: DSL18P
• Device Lot Number: MQCF140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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: 3 YR
• Patient Sex: Male
• Patient Weight: 12 KG