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

Model Number	MR17012601
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of returned device is in progress.A follow up report will be submitted when the evaluation 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
Vascular access team (vat) was requested to evaluate patient's picc due to report of difficult aspiration and air being aspirated from picc.Vat assessed picc and found that there was no blood return with aspiration, but only air.Unable to identify evidence of fracture; however, unable to flush the line with air in the catheter.
Additional Manufacturer Narrative
A 2.6f double lumen vascu-picc was returned for evaluation.The lumen was trimmed at the 19cm mark.A visual examination of the device revealed no obvious abnormalities or defects.A functional exam was performed.The red 21ga lumen aspirated and flushed without resistance or difficulty.No air was noted in the line.The white 23ga lumen could be aspirated and flushed, but with difficulty.No air was noted in the line.No leaks were identified.The reported failure could not be duplicated.A review of the manufacture records showed the device was manufactured according to specification with no non-conformances or abnormalities.No device failure was found.We are unable to determine the cause or factors that may have contributed to this event.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: 9930373
• Report Number: 2518902-2020-00019
• Device Sequence Number: 14144489
• Product Code: LJS
• UDI-Device Identifier: 00884908085693
• UDI-Public: 884908085693
• 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
• 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): 05/18/2020

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: 02/01/2022
• Device Model Number: MR17012601
• Device Catalogue Number: MR17012601
• Device Lot Number: MNRM760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/03/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/19/2020
• 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
• Patient Weight: 3