MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC

Model Number	MR17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	12/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 2.6f vascu-picc was returned for evaluation.Visual inspection confirmed a hole in the lumen approximately 1.5cm from the hub.The device was forwarded to medcomp engineering for further evaluation.Medcomp engineering reviewed the device including photographs under magnification.The photographs show the lumen stretched and burst as a result of pressure.A definitive root cause cannot be determined.
Event or Problem Description
Patient was found to have a saturated dressing at the picc site.The catheter was removed and noted upon flushing to have a fracture at the 1.5cm mark.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9636436
• Report Number: 2518902-2020-00001
• Device Sequence Number: 2913718
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MNQQ030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/28/2020
• 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: 17 MO
• Patient Weight: 9