MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 4F X 13CM PED. DBL. LUMEN; INFUSION CATHETER

Model Number MC2LP-313S

Device Problem Crack (1135)

Patient Problem Swelling/ Edema (4577)

Event Date 12/18/2022

Event Type  malfunction  

Event Description

Catheter showing loss of integrity (crack/crack) in the structure.The damaged part of the device was inside the patient, causing edema and leakage of administered solutions.

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.

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 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 instructions for use (ifu) contains the following warnings and precautions: do not use sharp instruments near the extension tubing or catheter lumen.Care must be taken when using sharp objects or needles in close proximity to catheter lumen.Contact from sharp objects may cause catheter failure.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: 4F X 13CM PED. DBL. LUMEN
• Type of Device: INFUSION CATHETER
• 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: 16400197
• MDR Text Key: 310069244
• Report Number: 2518902-2023-00014
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00884908028331
• UDI-Public: 00884908028331
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MC2LP-313S
• Device Catalogue Number: MC2LP-313S
• Device Lot Number: MMHS520
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention