MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX32CM SILIC HEMO-CATH SET; HEMO-CATH LT

Model Number SL32E.

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

The returned device sample is entering the investigation process.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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient receiving dialysis and clearances on dialysis getting progressively worse with no explanation.Contrast study showed split between lumens.Eventually unable to dialyze at all.Line replaced and problem solved.Appeared to be a split internally between the lumens of the line allowing recirculation of blood between the lumens preventing effective treatment.

Manufacturer Narrative

The contract manufacturer evaluated the returned device and confirmed the complaint.The review revealed the root cause was an incorrect distance between the mainshaft and extensions during the molding procedure, causing a thin wall between lumens and, after a period of use, the wall may break resulting in a cross lumen leak.The instructions to perform this operation is not clear regarding the use of a calibrated rule used to perform this operation to ensure the correct distance.To reduce the occurrence of this issue the molding procedure will be updated to clarify the use of the calibrated rule.Based on historic data this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.Device was used for treatment, not diagnosis.

• Brand Name: 12.5FX32CM SILIC HEMO-CATH SET
• Type of Device: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10308167
• MDR Text Key: 200472660
• Report Number: 2518902-2020-00030
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908046151
• UDI-Public: 884908046151
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Model Number: SL32E.
• Device Catalogue Number: SL32E.
• Device Lot Number: MHYS080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention