MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 3FX55CM SL PRO PICC CT-NURSING; PRO-PICC CT

Model Number	MR17033105
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
During insertion a hole in the lumen was noted.Device was replaced.Iatrogenic damage cannot be excluded as a cause.
Additional Manufacturer Narrative
Multiple requests for device return were unsuccessful.Video provided does confirm a leak in the lumen of the device.Information provided states that damage to the lumen by healthcare providers cannot be ruled out.Without an evaluation of the device a root cause cannot be determined.No further investigation is possible.If the device should be returned for evaluation the complaint will be reopened and the issue further investigated.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Device was returned for evaluation but was received in three (3) pieces.The lumen was cut approximately 0.01cm from the hub.A section of the lumen approximately 16 cm in length, as well as another section approximately 39 cm in length was also returned.It is not possible to determine which of the segments returned aligns with the hub.The exact location of the hole was not reported.With the lumen in pieces it is not possible to attempt to flush the lumen to determine the location of the hole.The picc was flushed and no leaks were detected.With the device returned in pieces further evaluation is not possible.A root cause cannot be determined.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 3FX55CM SL PRO PICC CT-NURSING
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10343509
• Report Number: 2518902-2020-00035
• Device Sequence Number: 3178442
• Product Code: LJS
• UDI-Device Identifier: 00884908096941
• UDI-Public: 884908096941
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2020

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: 11/19/2022
• Device Model Number: MR17033105
• Device Catalogue Number: MR17033105
• Device Lot Number: MNSX600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020; 07/23/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/23/2020; 11/18/2020
• 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