MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X 50CM DUAL VASCU-PICC

Model Number	MD17012601
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are awaiting additional information and clarification of the event.Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Placed picc.X-ray obtained.Pulled back catheter and was unable to flush.Catheter removed and line found to be cracked 2cm from tip.
Additional Manufacturer Narrative
No device was returned.A photograph was provided showing what appears to be a slice in the lumen, indicative of being cut with a sharp instrument.The slice/cut appears to be at an angle and through approximately 3/4 of the lumen diameter.As the lumen is implanted fully in the patient it is not exposed to sharp objects.It is not known if the device was checked for nicks or small cuts prior to insertion.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The device was inspected according to specification as well.This inspection included a 100% leak test of the device.This test would have detected the leak if it had occurred during the manufacture process.Without an evaluation of the device a root cause cannot be determined.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11813228
• Report Number: 2518902-2021-00025
• Device Sequence Number: 14401186
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 884908146493
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 08/01/2022
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MPFF010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No