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

Model Number	SL18P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient was implanted with the hemo-cath on (b)(6) 2020.On (b)(6) 2021 the patient's father found the catheter was broken while at home.Additional information shows the device was being used to infuse chemotherapy medication.Blinatumomab 38.5mcg vial blincyto was used.The issue occurred on the 26th day of a 28 day infusion treatment.
Additional Manufacturer Narrative
The 8f hemo-cath was returned for evaluation in three pieces.The lumen appears to have been cut off approximately 0.2cm from the hub.Two pieces of the lumen were also returned, one measuring approximately 8cm and the other approximately 5.5cm.When flushed the arterial extension line has a leak just below the over molded sleeve.Under magnification a small tear can be seen and the extension appears to have torn along the edge of the sleeve.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer conducted a review of the returned device.Their evaluation of the device confirmed the complaint as damage was noted on the arterial extension.A review of the manufacture records for the lot number reported revealed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as the last step in the process.This test would have detected the leak if it had existed at the time of manufacture.The hemo-cath is approved and indicated for hemodialysis and apheresis.It is not an infusion catheter and using it to infuse chemotherapy drugs is considered off label use.The event occurred after the device had been implanted for five months with no issues and was on the 26th day of a 28-day infusion.The device was manufactured according to specification and passed a robust leak test prior to packaging.A definitive root cause cannot be determined but is not likely related to the manufacture process.The instructions for use (ifu) contain the following precautions: do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.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: 8F X 18CM HEMO-CATH
• Common Device Name: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11406804
• Report Number: 2518902-2021-00013
• Device Sequence Number: 19902293
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 05/28/2024
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MMCH900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention