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

Model Number	9MRVSP26001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation 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
The day after insertion, femoral vein, it was noted the dressing was saturated and the picc was leaking.After removal it was noted there were 1 or two possible holes just distal to the hub.
Additional Manufacturer Narrative
No device was returned for evaluation and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as the last step in the process.This test would have revealed any holes, tears, leaks, or weak spots in the catheter if it existed at the time of manufacture.Without an evaluation of the device the complaint cannot be confirmed and a root cause cannot be determined but is not likely manufacture related.Difficulty removing the guidewire during the insertion procedure was reported.This issue may have contributed to the failure.The instructions for use (ifu) for the catheter contains the following precautions: do not use sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.If difficulty and/or bunching of the catheter lumen are experienced while removing the stylet, additional flushing of the catheter may be helpful.The catheter may need to be repositioned 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 TLS
• Common Device Name: VASCU-PICC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 12460073
• Report Number: 2518902-2021-00057
• Device Sequence Number: 16445858
• Product Code: LJS
• UDI-Device Identifier: 00884908147230
• UDI-Public: 884908147230
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K120981
• 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: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 05/25/2024
• Device Model Number: 9MRVSP26001
• Device Catalogue Number: 9MRVSP26001
• Device Lot Number: MMGZ160
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 09/29/2021
• 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 Age: 6 WK
• Patient Weight: 1