MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13F X 20CM DUO-SPLIT IJ CATHETER; DUO-SPLIT ST HEMODIALYSIS CATHETER

Model Number DSP138PSE

Device Problem Crack (1135)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Death  

Event Description

"when the device was introduced to function, we saw leaking on both outports/ports.Also during the dialysis the port expelled the blood and didn't allow to return.".

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for additional information regarding the incident and for the return of the catheter 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.

Manufacturer Narrative

Received one intact 13f x 15cm duo-split catheter for evaluation.A visual evaluation denoted no obvious defects.The extension tubing is slightly discolored.There is no damage or leakage from the red luer.The blue luer has a visible crack 1.0cm in length and appears to be next to the luer knit line.When flushing the device, a small stream leaks from the crack.No leakage occurs when the device is not under pressure.Under magnification, there appears to be damage to the luer wings that may have been caused by the use of an instrument on the luer.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.We are unable to determine the cause or factors that may have contributed to this event.The female luers are manufactured to meet the iso standard.A common cause of cracked luers is over-tightening of connections.The ergonomically shaped luer provides users with a patent locking design.This assures obtaining a secure mating of the catheter without the need to torque down.

• Brand Name: 13F X 20CM DUO-SPLIT IJ CATHETER
• Type of Device: DUO-SPLIT ST HEMODIALYSIS 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 18055449
• MDR Text Key: 327161944
• Report Number: 2518902-2023-00071
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: DR
• 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: 01/02/2024

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: DSP138PSE
• Device Catalogue Number: DSP138PSE
• Device Lot Number: MQRV390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 10/31/2023
• Supplement Dates FDA Received: 01/02/2024
• Date Device Manufactured: 04/18/2023
• 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): Death
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 50 KG