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

Model Number MD17012601

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

The device involved in the incident was not returned for evaluation and no photographs of the failure were provided.A thorough investigation of product design and manufacturing processes was performed by medcomp engineering in conjunction with the device contract manufacturer.Actions will be implemented to minimize this type of occurrence if determined to be required.The device subassembly is received from an external supplier and is visually and functionally inspected.Incoming inspection includes visual inspection for kinks, holes, gaps, and functional testing for leaks.At the completion of the final manufacture processes, the catheters are 100% leak tested.Catheter lumens with damage, such as holes, ruptures, tears and/or small pinholes will be detected during this test.Excessive external pressure applied to the lumen may be a contributing cause for this type of failure.A definitive root cause of the failure could not 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.If resistance is encountered to aspirating or flushing, the lumen may be partially or completely occluded.Warning: do not flush against resistance.Do not use infusion equipment which can exceed the working pressure of 1.0bar max/750mmhg (15.5 psi).Only use infusion equipment complying with standards, which do not exceed a shut-off pressure of 1.0bar.Bolus injections should be slow and must not exceed the maximum bolus pressure of 1.2bar/900mmhg (17.4 psi).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 Description

The extension with the white clamp was heparin locked.The extension with the red clamp was infusing with a carrier solution of normal saline a 2 ml/hour at the time leaking was noted at the insertion site.When the infusion was disconnected and the extension with the red clamp was flushed, leaking was noted from the insertion site.The exact location of the leak on the white lumen was not reported and the catheter was not saved.

• Brand Name: 2.6F X 50CM DUAL VASCU-PICC
• Type of Device: 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: 18616020
• MDR Text Key: 334769837
• Report Number: 2518902-2024-00011
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00884908146493
• UDI-Public: 00884908146493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102966
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MD17012601
• Device Catalogue Number: MD17012601
• Device Lot Number: MQYL500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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
• Patient Age: 3 MO
• Patient Sex: Female
• Patient Weight: 5 KG