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	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Catheter was trimmed to 23cm and successfully inserted in right basilica vein.Two weeks later when trying to flush the white luer a little resistance was met.Upon further investigation the dressing site was completely wet from flushing attempts.The decision was made by a fellow to cap off the white luer and attempt to use the red luer.Eventually the same effect occurred on the red luer.The line was removed and upon inspection of the line it seemed to be leaking where the luers and the tubing connect.
Additional Manufacturer Narrative
One 2.6f vascu-picc was returned for evaluation.The lumen was trimmed at the 23cm mark.No visual damage to the catheter was noted.A functional evaluation determined both extensions leak at the luer junction when the device is flushed.The device was forwarded to the contract manufacturer for evaluation and investigation.Inspection of the device showed that there appears to be a tear of the extension just above the distal end of the luer and the extension also appears to have a narrowing, usually exhibited due to stretching.Each extension exhibits a tear approximately 2mm above the distal end of the luer.Based on the investigation of the manufacture process and the returned device, we are not able to determine a possible root cause for this issue.

• 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: 7482775
• Report Number: 2518902-2018-00030
• Device Sequence Number: 1476620
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 09/29/2020
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MJLM470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/01/2019
• 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