MAUDE Adverse Event Report: MEDCOMP 5FX60CM SGL PRO PICC CT-BASIC; PRO-PICC CT

Model Number	MR17035101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one 5fx60cm sgl pro picc.Customer reported "leakage from a hole in the extension line was detected immediately after device was implanted".A flush test was used to locate the area of leakage in the extension tube.Closer examination under 10x magnification revealed a tear on the extension, which appears to have been made from a sharp object.The manufacture process has steps throughout the process to test for and detect leaks.The tear on the extension was clearly made by a sharp instrument, such as a scalpel.Any such tear would have been detected during the manufacture and inspection process.It is believed this cut occurred after the device package was opened.
Event or Problem Description
Leakage from a hole in the extension line was detected immediately after device was implanted.

• Brand Name: 5FX60CM SGL PRO PICC CT-BASIC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8840712
• Report Number: 2518902-2019-00042
• Device Sequence Number: 205879
• Product Code: LJS
• UDI-Device Identifier: 00884908033168
• UDI-Public: 884908033168
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2021
• Device Model Number: MR17035101
• Device Catalogue Number: MR17035101
• Device Lot Number: MLDZ150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/30/2019
• 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 Age: 65 YR