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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A hole was noted in the white lumen.The hole is between the catheter lumen and catheter wing.Catecholmine therapy could not be adequately administered and the patient showed increasing signs of heart failure.
Additional Manufacturer Narrative
We are currently waiting 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
One 2.6f double lumen vascu-picc was returned for evaluation.The lumen length is 50 cm indicating the lumen has not been trimmed.A functional examination was performed by flushing each lumen with water using a 10cc syringe.When flushing the lumen with the white clamp, a leak was noted at just proximal to the 24cm mark.Under magnification the damage to the lumen appears to be "v" shaped.When flushing the lumen with the red clamp, no leaks were noted.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.We are unable to determine the cause or factors that may have contributed to this event.

• 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: 15868429
• Report Number: 2518902-2022-00068
• Device Sequence Number: 20531542
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 06/30/2024
• Device Model Number: MR170126024S
• Device Catalogue Number: MR170126024S
• Device Lot Number: MQHF350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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