MAUDE Adverse Event Report: MEDCOMP 2.6F X 50CM DUAL LUMEN PICC; VASCU-PICC INFUSION CATHETER

Model Number	MR17012601
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter was placed in patient on (b)(6) 2018.Discovered on (b)(6) 2018 that catheter had broken at hub.Email stated that the "crack likely could be related to inappropriate care/maintenance after blood transfusion" no patient injury.Catheter was pulled and replaced the catheter with another vascu picc on (b)(6) 2018.
Additional Manufacturer Narrative
Based on dhr review and process review performed, it was concluded that involved lot was manufactured according to design specifications and requirements.Reported failure mode is not attributable to the manufacturing process.The information provided stated the"crack likely could be related to inappropriate care/maintenance after blood transfusion".

• Brand Name: 2.6F X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC INFUSION CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7751653
• Report Number: 2518902-2018-00047
• Device Sequence Number: 1719840
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

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: 02/17/2021
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MLDF720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 12/27/2018
• 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