MAUDE Adverse Event Report: MEDCOMP 6FX60CM DL PROLINE CT; PRO-LINE CT

Model Number	MR28036221
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.The device was forwarded to the contract manufacturer for evaluation and investigation.When the investigation is complete a final report will be submitted.
Event or Problem Description
After catheter was placed a pin hole was noticed just below the hub.The catheter was removed and a new catheter placed.The patient was not impacted.
Additional Manufacturer Narrative
One 6f double lumen pro-line catheter was returned for evaluation.The lumen is trimmed at the 21cm mark.A visual and functional evaluation revealed a hole at the lumen to hub junction that leaks when the device is flushed.The device was forwarded to the contract manufacturer for evaluation and investigation.Based on the investigation, a root cause could not be determined.All catheters are 100% leaked tested during the manufacturing process, but the failure mode may have taken place after testing and missed during quality inspection.All processes and procedures have been reviewed and updated to help minimize this type of occurrence in the future.

• Brand Name: 6FX60CM DL PROLINE CT
• Common Device Name: PRO-LINE CT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6710323
• Report Number: 2518902-2017-00037
• Device Sequence Number: 187771
• Product Code: LJS
• UDI-Device Identifier: 00884908094275
• UDI-Public: 884908094275
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/13/2018

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: 11/26/2019
• Device Model Number: MR28036221
• Device Catalogue Number: MR28036221
• Device Lot Number: MHTG750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 06/15/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 03/13/2018
• 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