MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13.5F X 24CM SILICONE CATHETER; HEMO-CATH ST

Model Number ECS1324

Device Problem Leak/Splash (1354)

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

Event Date 12/05/2021

Event Type  malfunction  

Manufacturer Narrative

We are currently waiting for additional information.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

I inserted a vascath into patient due to his aki.It was an easy procedure and cxr and vbg confirmed a correctly sited line.Upon initiating rrt the nursing staff reported difficulty in aspirating blood from the blue lumen of the vascath and noticed it was possible to aspirate air from this lumen.After rewiring the vascath we noticed that there was a small crack in the vascath (white part just distal to the securing point.).

Manufacturer Narrative

No device was returned for evaluation.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 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.Without an evaluation of the device a root cause cannot be determined.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: 13.5F X 24CM SILICONE CATHETER
• Type of Device: HEMO-CATH ST
• 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: 13253051
• MDR Text Key: 289489738
• Report Number: 2518902-2022-00010
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00541376500527
• UDI-Public: 541376500527
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ECS1324
• Device Catalogue Number: ECS1324
• Device Lot Number: MNMM580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2019
• 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