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

Model Number	MR17012601
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Date of Event	07/14/2017
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
The picc was in the patient for about three days with tpn running through it.The nurse told ir that the line infiltrated.
Additional Manufacturer Narrative
Received a 2.6 f picc for evaluation.A visual inspection revealed the catheter to be trimmed at 22cm mark with no damage or defects noted.A functional evaluation showed the lumen to leak at the 2cm mark.The device was forwarded to the device manufacturer for evaluation.Inspection records, device history records and inspection of the returned sample were performed.The exact root cause of the failure could not be determined.The failure mode could have been caused by a single or combination of factors that have been identified during the comprehensive investigation which was conducted by the contract manufacturer and the medcomp engineering department.Actions have been implemented by the contract manufacturer in order to minimize this type of occurrence.

• 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: 6793737
• Report Number: 2518902-2017-00041
• Device Sequence Number: 101528
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2018

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: 10/05/2019
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MHWA820
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 04/20/2018
• 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