MAUDE Adverse Event Report: MEDCOMP 6FX60CM DUAL PRO LINE CT-BASIC; PRO-LINE CT

Model Number	MR28036201
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received a 6f dl pro- line for evaluation.A visual inspection revealed a rupture with the lumen at the between the 7 and 8 cm marks.The pro- line was forwarded to the device contract manufacturer for evaluation.
Event or Problem Description
Catheter placed on (b)(6).Worked well when placed.Patient returned for exchange.Chest x-ray showed damage.
Additional Manufacturer Narrative
Root cause cannot be attributed to the manufacturing processes as the catheter met dimensional requirements.The lumen rupture may have been the result of the unknown foreign material collecting in the catheter, fully obstructing the lumen.

• Brand Name: 6FX60CM DUAL PRO LINE CT-BASIC
• Common Device Name: PRO-LINE CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7037647
• Report Number: 2518902-2017-00061
• Device Sequence Number: 16397454
• Product Code: LJS
• UDI-Device Identifier: 00884908034622
• UDI-Public: 884908034622
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K093309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2018

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: 12/09/2019
• Device Model Number: MR28036201
• Device Catalogue Number: MR28036201
• Device Lot Number: MHYW440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 08/30/2018
• 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
• Patient Age: 4 YR