MAUDE Adverse Event Report: MEDCOMP 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	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report mw5082411 was received from the fda.An investigation has been initiated.
Event or Problem Description
Picc located on right upper arm.Swelling noted to arm, ultrasound performed on (b)(6) 2018 that was negative for clot formation @ picc site.On (b)(6) 2018 picc line discontinued and found to have hole in it.
Additional Manufacturer Narrative
Review of the returned device revealed a tear between the 13cm and 14cm depth markings and estimated to be approximately 0.887 cm in length.A liquid leak test showed the lumen damage corresponded to the white luer.No leak was observed when flushing the red luer.The wall thicknesses of the lumen were within specifications.The device was manufactured to specifications and all relevant dimensions taken remain within specifications, the root cause of the burst lumen cannot be determined.

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8270083
• Report Number: 2518902-2019-00011
• Device Sequence Number: 1616839
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019
• Report Date (Section F): 12/28/2018

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: 08/31/2021
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MLNH110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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
• Patient Weight: 7