MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13.5FX20CM SIL DBL LMN W/STYLET; HEMO-CATH ST

Model Number SDL138E.

Device Problem Leak/Splash (1354)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

We are currently waiting for additional information 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.

Event Description

During hemodialysis treatment air was noted in the arterial extension.

Manufacturer Narrative

The 13.5f silicone hemo-cath was returned for evaluation.As it was reported air was noted in the arterial extension, the distal tip of the lumen was clamped and the arterial side was flushed.No leaks were noted.The venous side was then flushed revealing a leak in the lumen approximately 0.1 cm from the hub.Under magnification the leak appears to originate from an external puncture.The contract manufacturer conducted a review of the manufacture process for the lot number reported.Their investigation revealed nothing out of specification, no amv (authorized manufacturer variance), ncr (non-conformance report) or reworks related to the reported failure mode were found.Lot was manufactured according to specifications.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.A definitive root cause cannot be determined but is not likely manufacture related.The instructions for use (ifu) contains the following warnings and precautions: *do not use sharp instruments near the extension lines or tubing.*examine catheter lumens and extensions before and after each treatment for damage.

• Brand Name: 13.5FX20CM SIL DBL LMN W/STYLET
• 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: 17689808
• MDR Text Key: 322717582
• Report Number: 2518902-2023-00058
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SDL138E.
• Device Catalogue Number: SDL138E.
• Device Lot Number: MQVA470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2023
• 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