MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4FX55CM SGL PRO PICC CT-BASIC; PRO-PICC CT

Model Number	MR17034101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
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
After implantation it was not possible to flush and not aspirate blood.When the catheter was flushed, liquid came out from the puncture site.The doctor pulled the picc.The picc has a split after 5-6 cm from the puncture site towards the heart.The doctor implanted a new picc from the same puncture site.
Additional Manufacturer Narrative
The 4f pro picc was returned for evaluation.Visual inspection revealed what appears to be a slice near the 6cm mark.When viewed under a microscope the slice is smooth, consistent with being cut with a sharp instrument such as a scalpel.A tear or burst would have a more jagged appearance.Definitive root cause cannot be determined but is most likely not manufacture related.The instructions for use (ifu) contains the following catheter precautions: do not use sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.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: 4FX55CM SGL PRO PICC CT-BASIC
• Common Device Name: PRO-PICC CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10344266
• Report Number: 2518902-2020-00037
• Device Sequence Number: 19627715
• Product Code: LJS
• UDI-Device Identifier: 00884908033069
• UDI-Public: 884908033069
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/14/2020

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: 02/20/2022
• Device Model Number: MR17034101
• Device Catalogue Number: MR17034101
• Device Lot Number: MNGD600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 08/14/2020
• 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
• Patient Age: 19 YR