MAUDE Adverse Event Report: MEDCOMP 2.6F X 50CM DUAL LUMEN PICC W/MST; VASCU-PICC

Model Number	MR170126024S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
When the catheter was flushed, the line was leaking at the insertion site.It appears that the lumen had burst.Catheter was removed.
Additional Manufacturer Narrative
A review of the dhr and manufacture process, including leak testing, revealed this lot was manufactured to specification.The reported failure was not attributed to the manufacture process.We are unable to determine the cause or factors that may have contributed to this event.Potential causes that might cause damage to the catheter include flushing against resistance, such as a clot or a kink in the catheter, use of a syringe smaller than 10cc, bolus injections exceeding maximum bolus pressure of as stated in the instructions for use.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC W/MST
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8587135
• Report Number: 2518902-2019-00028
• Device Sequence Number: 1809622
• Product Code: LJS
• UDI-Device Identifier: 00884908105131
• UDI-Public: 884908105131
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• 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,Followup
• Report Date (Section B): 06/14/2019

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: 06/30/2021
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MMAN420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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