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

Model Number	MD17012601
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for additional information and the return of the device 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.
Event or Problem Description
Line placed by picc team to left basilic vein.Both lumens ruptured at 1cm mark (which was at the skin exit site).The picc team received a call from the icu nurse reporting wetness at site.Two picc nurses then went to bedside, removed dressing, and while flushing line, observed leaking.After a conversation with the physician, line was removed.Per the bedside nurse, there had been no problems with the line, both lumens were infusing continuously, and she had completed a cap change on both lumens earlier in the day, both with positive blood return and flushing easily.The nurse was drawing labs this afternoon when she observed "leaking" from the site.Upon further investigation, i observed both lumens leaking at the first black line (1cm mark).
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.Visual inspection revealed a leak in the lumen approximately 1.5 cm from the hub.Under magnification the hole appears to be a cut and not a tear.The lumen appears to have been scored with a sharp instrument such as a scalpel or scissors just below the actual cut.The device contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation showed the device was manufactured according to specification with no non-conformances or abnormalities.A root cause cannot be determined.We are not able to determine the circumstances that may have led to this event.The instructions for use (ifu) contains the following precautions: do not use sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.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 X 50CM DUAL VASCU-PICC
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11272764
• Report Number: 2518902-2021-00005
• Device Sequence Number: 584476
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 884908146493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102966
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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: 08/01/2022
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MPGT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/02/2021
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/19/2021
• 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 Weight: 19