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

Model Number	SL18P
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.A video provided by the customer shows ballooning of the venous extension immediately below the over-molded protective sleeve while flushing the catheter.The video was sent to contract manufacturer and a review of the manufacture records was requested.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
The arterial extension ballooned during dialysis.
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.A video provided by the customer shows intermittent ballooning of the venous extension immediately below the overmolded protective sleeve while flushing the catheter.The video was sent to contract manufacturer and a review of the manufacture records was requested.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their review showed the device was manufactured according to specification with no non-conformances or abnormalities.While the video did confirm the complaint an evaluation of the device cannot be conducted without inspection of the actual device.Without an evaluation of the device a definitive root cause cannot be determined.The extension tubing may have been over pressurized causing the silicone material to weaken.This led to the ballooning of the extension when it was flushed.Based on historic data this is not a systemic issue and is considered an isolated incident.Device was used for treatment, not diagnosis.

• 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: 10942154
• Report Number: 2518902-2020-00061
• Device Sequence Number: 19561651
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: ES
• PMA/510(K) Number: K893439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 10/22/2022
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MKAH010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 12/21/2020
• 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
• Patient Age: 2 YR
• Patient Weight: 13