MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12FX20CM STRAIGHT TPL LMN; TRIPLE LUMEN CATHETER

Model Number ART1220S

Device Problem Disconnection (1171)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

Disconnection from the catheter of the fastening flap of the stitches with partial removal of the same and need for new positioning with temporary interruption of the renal replacement therapy.

Manufacturer Narrative

We are currently waiting 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.

Manufacturer Narrative

The triple lumen catheter was returned for evaluation with the suture wing separated from the catheter hub.Sutures were attached to the suture wing.The hub and inner diameter of the suture wing showed no obvious defects.A supplier corrective action request (scar) was issued to the contract manufacturer.Dimensional measurements were taken of the returned sample.The notch depth of the hub and the suture wing inner id are in specification.These dimensions are what prevent the suture wing from separating from the hub.The operation to attach the suture wing to the hub is performed by hand.A small drop of silicone fluid is applied, and the suture wing is placed by pushing the wing onto the hub until it is properly seated in the correct position on the hub.The operator rotates the wing a few times to ensure that it turns freely on the hub.The operator wipes all excess silicone from the hub.An aql inspection is performed to verify the wing is applied to the hub securely, seated properly in the groove and rotates freely.During inspection no problems were found.The investigation concluded that the reported failure may have been caused by incorrect assembly of the suture wing to the hub due to operator error.Retraining of operators has been completed.Product design verification/ validation testing has been performed.Suture wing integrity was tested in accordance with en iso 10555-1:2013+a1:2017 intravascular catheters - sterile, single-use catheters part 1: annex b, and using the zwick tensile tester after transit conditioning and when processed through two (2) eo sterilization cycles.All samples tested in this protocol met the acceptance criteria for suture wing integrity.

• Brand Name: 12FX20CM STRAIGHT TPL LMN
• Type of Device: TRIPLE LUMEN 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: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 17748410
• MDR Text Key: 323902235
• Report Number: 2518902-2023-00062
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/16/2023

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: ART1220S
• Device Catalogue Number: ART1220S
• Device Lot Number: MPTS640
• 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: 09/13/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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
• Patient Age: 66 YR