MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 7F X 7CM DUO-FLOW DBL LMN SET; SOFT-LINE CATHETER

Model Number	DT73M
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
Our investigation is ongoing.Additional information has been requested from the user facility.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
Patient had existing dialysis catheter, patient was having an off circuit exchange on aquadex machine when initiating flow on the new machine air was noted in the blue withdraw line.Aquadex stopped, line clamped, reprimed with new circuit.When initiating the second time air was being pulled into the new aquadex circuit.Rn clamped and stopped aquadex and flushed withdraw port and flushed saline and noted saline leaking from blue port.
Additional Manufacturer Narrative
The complained device was not returned for evaluation and no photographs were provided.Multiple requests for clarification and additional information were unsuccessful.The contract manufacturer conducted a review of the manufacture records for the lot number provided.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.Without an evaluation of the device and without the clarification and additional information requested a root cause cannot be determined.From the incident description it appears the blue female luer (port) cracked.The female luers are manufactured t0 the iso standard.A common cause of cracked luers is over-tightening of connections.The ergonomically shaped luer provides users with a patent locking design.This assures obtaining a secure mating of the catheter without the need to torque down.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: 7F X 7CM DUO-FLOW DBL LMN SET
• Common Device Name: SOFT-LINE 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: 14958801
• Report Number: 2518902-2022-00045
• Device Sequence Number: 15189897
• Product Code: MPB
• UDI-Device Identifier: 00884908143379
• UDI-Public: 884908143379
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K983511
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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: 06/08/2024
• Device Model Number: DT73M
• Device Catalogue Number: DT73M
• Device Lot Number: MQDJ350
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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 Sex: Unknown