MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F X 20CM DBL CT MIDLINE

Model Number	MLCT5D20
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the device to be returned for evaluation.
Event or Problem Description
During power infusion, leakage in the subcutaneous tissue was noted.When the catheter was removed, a small crack was noted around 2cm from the hub.
Additional Manufacturer Narrative
The 5f midline was returned for evaluation.Visual inspection of the device revealed a hole in the lumen approximately 0.3cm in length at the 4cm mark.The lumen also appears to "curve" at the 4cm mark.Medcomp engineering reviewed the device and confirmed that the lumen appears to have burst at the 4cm depth mark as a result of excessive pressure.The lumen stretched and burst.The manufacture records were reviewed and no non-conformances or variances were noted.Root cause cannot be determined.

• Brand Name: 5F X 20CM DBL CT MIDLINE
• Common Device Name: CT MIDLINE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9590526
• Report Number: 2518902-2019-00084
• Device Sequence Number: 11391390
• Product Code: PND
• UDI-Device Identifier: 00884908113754
• UDI-Public: 884908113754
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 12/03/2021
• Device Model Number: MLCT5D20
• Device Catalogue Number: MLCT5D20
• Device Lot Number: MNCJ240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/20/2020
• 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