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

Model Number	MR17012600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A chest x-ray demonstrated what appeared to be a fractured 2.6 f dual lumen picc in situ at the level of the lt brachiocephalic vein.
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 available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Approximately 13 cm of the device lumen was returned for evaluation.Visual inspection reveals a tear in the lumen approximately 11 cm from one end.A great deal of dried blood can be seen inside the lumen on both sides of the tear.The tear is consistent with the lumen rupturing under pressure.If resistance was encountered when flushing the device or when injecting medications, the lumen could have undergone stresses it was not designed to withstand.The device was implanted for 12 days prior to the incident.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any holes, leaks, or weak areas if they had existed at the time of manufacture.Root cause of this event cannot be determined.The instructions for use (ifu) contains the following warnings and precautions: do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (14.5 psi).Only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0bar.Bolus injections should be slow and must not exceed the maximum bolus small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.Do not flush against resistance.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 X50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 13394699
• Report Number: 2518902-2022-00014
• Device Sequence Number: 4525164
• Product Code: LJS
• UDI-Device Identifier: 00884908093711
• UDI-Public: 884908093711
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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: 08/15/2023
• Device Model Number: MR17012600
• Device Catalogue Number: MR17012600
• Device Lot Number: MPFL140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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 Sex: Unknown