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

Model Number	MR170126024S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Picc was fixed by default but was disconnected at the catheter connection point.
Additional Manufacturer Narrative
An investigation has been initiated.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
The device involved in the incident was not returned for evaluation.One photograph was provided showing the picc extensions and hub with no lumen attached.The photograph is insufficient to determine a possible root cause.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 leaks, holes, or weak spots if it had existed at the time of manufacture.The device was implanted for 8 days with no reported issues.Without an evaluation of the device a root cause cannot be determined.The instructions for use (ifu) contains the following warnings and precautions: *small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.*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.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned for evaluation.The complaint was reopened.The returned device is in two pieces with 17 cm of the lumen separated from the picc at the hub.Visual inspection revealed that the lumen is torn just inside the hub.The device was evaluated by medcomp engineering.Under magnification the proximal end of the lumen can be seen inside the hub, indicating the lumen was placed correctly during the hub molding process.The ends of the lumen are jagged which is indicative of the lumen being torn.The condition of the returned device suggests the lumen may have been pulled with more force than it is designed to withstand, causing the lumen to tear off.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 manufacturing process includes a 100% leak test performed as a last step in the process.This test would have detected any leaks, holes, or weak spots if it had existed at the time of manufacture.The device was implanted for 8 days with no reported issues.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.This would include flushing or infusing against resistance, inadequate securement of the device, and pull force applied to the device resulting in the failure mode.The instructions for use (ifu) contains the following warnings and precautions: *small syringes will generate excessive pressure and may damage the catheter.The use of 10cc or larger syringes are recommended.*do not use sharp instruments near the extension lines or catheter lumen.*do not use scissors to remove dressing.*insertion site and external portion of the catheter should always be covered with a protective 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 LUMEN PICC W/MST
• 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: 18875762
• Report Number: 2518902-2024-00019
• Device Sequence Number: 9069126
• Product Code: LJS
• UDI-Device Identifier: 00884908105131
• UDI-Public: 00884908105131
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2024

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?: No
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MQWX800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 03/08/2024; Not provided
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/27/2024; 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown