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	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device sample is available but has not yet been returned.When the sample is received and the investigation is complete a supplemental report will be submitted.
Event or Problem Description
Extension tubing ballooning when pressure applied.
Additional Manufacturer Narrative
Without an evaluation of the device no root cause determination can be made.It appears that 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.This type of event will be trended through the complaint handling process.

• 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: 8887318
• Report Number: 2518902-2019-00051
• Device Sequence Number: 19289932
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: 10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 01/31/2020
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Device Lot Number: MCGA370
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1