MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13.5F X 35CM SILICONE DBL LMN; ST HEMO-CATH

Model Number SDL1314E

Device Problem Leak/Splash (1354)

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

Event Date 12/12/2021

Event Type  malfunction  

Event Description

Catheter inserted by the doctor.Test of way was done.Start of dialysis session.No complication reported during the first 2 hours and then we have identified a blood leak come from the venous way with an important quantity of blood in the patient's bed.

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

The device was returned for evaluation.Catheter lot number taken directly from returned device.Visual inspection confirms the complaint as a leak was noted in the extension tubing.Under magnification it can be seen that there are two holes/pinch marks on the tubing.These marks are 180 degrees across from each other.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 manufacture process.This test would have detected any leaks, holes, or weak spots if they 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 precautions: *do not use sharp instruments near the extension lines or tubing.Do not use scissors to remove dressing.Clamping the catheter repeatedly in the same location will weaken tubing.Avoid clamping near the luers and hub of the catheter.Do not clamp over guidewire or stylet - tubing may become damaged.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 35CM SILICONE DBL LMN
• Type of Device: ST HEMO-CATH
• 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: 13051983
• MDR Text Key: 284528387
• Report Number: 2518902-2021-00072
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00884908042313
• UDI-Public: 884908042313
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

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
• Device Operator: Other
• Device Model Number: SDL1314E
• Device Catalogue Number: SDL1314E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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