MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 1.9FX50CM SGL LMN V-P BASC KIT; VASCU-PICC

Model Number	MR17011101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was received and is currently undergoing the investigation process.Once the investigation is complete we will submit a follow up report.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
Picc line in patient.Line broke at wing connection.
Additional Manufacturer Narrative
The 1.9f picc was returned for evaluation in two pieces.Visual inspection reveals the lumen broke off at the hub.Medcomp engineering reviewed the device and determined the contract manufacturer should confirm whether the lumen depth in the hub is within specification.The device was forwarded to the contract manufacturer and the depth of the lumen inside the hub was confirmed to be within specification.A review of the manufacture records revealed the device was manufactured according to specification.A root cause cannot be determined but is most likely not manufacture related.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: 1.9FX50CM SGL LMN V-P BASC KIT
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10290840
• Report Number: 2518902-2020-00029
• Device Sequence Number: 14276362
• Product Code: LJS
• UDI-Device Identifier: 00884908032659
• UDI-Public: 884908032659
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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: 09/06/2022
• Device Model Number: MR17011101
• Device Catalogue Number: MR17011101
• Device Lot Number: MNQQ010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 10/13/2020
• 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