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

Model Number	MR17012601
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device is in progress.A follow up report will be submitted when the evaluation is completed.
Event or Problem Description
After placing the picc line an attempt was made to flush both lumens.As the red lumen was flushed with the t-piece/wire still connected to the end of the picc, blood began backing up into the other white lumen.Picc was removed and replaced with another and no further issues were noted.
Additional Manufacturer Narrative
The vascu picc was returned for evaluation with the side port and stylet still in place.The contract manufacturer evaluated the returned device.The sample was in good condition and did not exhibit any damage.A cross lumen leak test was performed on both sides of the catheter.No cross-lumen leakage and no leaks of any kind were found.A review of the manufacture records for this lot was conducted and found the device was manufactured according to specification.Based on the record review and the evaluation of the returned device, a root cause for the issue reported cannot be determined.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 X 50CM DUAL LUMEN PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9828726
• Report Number: 2518902-2020-00017
• Device Sequence Number: 2886546
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/01/2022
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MNQQ030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Weight: 4