MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 2.6F X50CM DUAL VASCU-PICC

Model Number	MR17012600
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is expected to be returned for evaluation but has not yet been received.
Event or Problem Description
During basic care it was noted that the lumen was cracked between the 0 and 2 cm mark.Catheter was scheduled to be removed later that day but was removed 4 hours earlier than planned with no influence to the condition of the patient.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation in two pieces.The hub was received with the extensions and luers intact and a 3cm length of lumen attached to the hub.A 33cm section of lumen was also received.The end of the lumen appears to be a smooth break.The device and incident information were reviewed by medcomp engineering.Without the lot number of the device a review of the manufacture records was not possible.Visual inspection of the portion of the lumen connected to the hub indicated the lumen end flares and is discolored.The side assumed to be opposite the break is deformed and necks down slightly.Something appears to have happened to the catheter in addition to a break from tensile strain.The distal end of the lumen appears normal.A definitive root cause cannot be determined.The device was implanted for 44 days in a 2-month-old infant.It is possible that the device was subjected to tensile strain due to movement of the child during the implanted period contributing to the device failure.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: 2.6F X50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9817310
• Report Number: 2518902-2020-00013
• Device Sequence Number: 19023657
• Product Code: LJS
• UDI-Device Identifier: 00884908093711
• UDI-Public: 884908093711
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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 Model Number: MR17012600
• Device Catalogue Number: MR17012600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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: 2 MO