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	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Difficult picc insertion.Afterwards almost not flushable, then high run rate.Torn off during movement of the child.Picc could completely be removed immediately.
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for additional information regarding the incident and for the device to be returned 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.
Additional Manufacturer Narrative
The 2.6f vascu picc was returned in two pieces.Approximately 46 cm of the lumen was returned with the adhesive attached.There was no lumen attached to the hub of the picc.Blood could be seen throughout the length of the lumen that could not be removed.The device was viewed under magnification.The end of the lumen that was attached to the hub is torn as the edges are jagged.There is lumen within the hub of the catheter also with jagged edges indicating the lumen was torn.The device was further reviewed by medcomp engineering.It was determined the lumen was most likely subjected to with more force than it is designed to withstand, thus causing it to tear.The contract manufacturer conducted a review of the manufacturing records for the device 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.Additional information provided indicated the catheter was flushed with small syringes (1ml and 2ml).The instructions for use include a caution that reads, "small syringes will generate excessive pressure and may damage the catheter.Ten (10cc) or larger syringes are recommended." the information also stated a high flow rate was used, ~60ml/hr.The instructions for use include warnings for infusion equipment and bolus injections.Failure to follow these instructions may lead to catheter failure.In addition, the information provided stated the catheter "tore off during movement of the child." a definitive root cause for the failure could not be determined, however the information suggests a mishandled device and possible user error.There is no evidence of a manufacturing issue.

• 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 19213672
• Report Number: 2518902-2024-00031
• Device Sequence Number: 12822298
• 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
• Report Date (Section B): 05/22/2024

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: 04/30/2026
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MRAD280
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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