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

Model Number	MR17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Swelling (2091); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a final report will be submitted.
Event or Problem Description
Catheter occlusion-t-pa instilled and dwelled for 90 min.Patency restored.Iv fluids restarted.Three hours later patient has leg swelling and repeat catheter occlusion.Dressing removed and kink in the catheter was discovered.Once unkinked the catheter flushed easily.Leaking noted at insertion site when flushed.Picc removed and a fracture was noted (external catheter length 6cm, fracture at 8cm).
Additional Manufacturer Narrative
Inspection records, device history records and inspection of the returned sample were performed.The root cause of the failure could not be determined.

• 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: 6508492
• Report Number: 2518902-2017-00017
• Device Sequence Number: 994927
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2017

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 Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MHWA820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: 4