MAUDE Adverse Event Report: MOLDED PRODUCTS MPC-130; SEE LUER CAP SET

Catalog Number	MPC-130
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product had been requested to be removed from use more than a month before the incident occured.Distributors had been notified to remove this lot and also directed to contact any facilities that had received the affected lot.In review of the nonconformance it was determined the product had not been assembled in accordance with the established assembly protocol.Training was inadequately done.Corrective actions have been instituted.
Event or Problem Description
An original report was created on (b)(6) 2026; event # (b)(4); a product recall was initiated at that time.Molded products was advised (b)(6) 2026 that a new event had occurred that included the same product manufactured by molded products.Mpc-130 see luer cap set lot# 20389 was deemed nonconforming due to being assembled incorrectly.The luer pin was not snapped into the thread cap which would cause the two pieces to disengage.This nonconformance is easily spotted as the luer pin will come out as soon as the cap is screwed onto the catheter or it will already be disassembled in the package.A proceduralist at a radiology suite did not notice the nonconformance and proceeded to use the product on a patient.The product should not have been available for use as it had been documented for recall, and all distributors had been contacted with the recall information.The patient had to have an additional procedure done to replace a potentially contaminated dialysis line no blood loss noted and no reported injury noted.

• Brand Name: MPC-130
• Common Device Name: SEE LUER CAP SET
• Manufacturer (Section D): MOLDED PRODUCTS; 1812 industrial pkwy; harlan IA 51537
• Manufacturer (Section G): MOLDED PRODUCTS; 1812 industrial pkwy; harlan IA 51537
• Manufacturer Contact: teresa wooster ; 1812 industrial pkwy; harlan, IA 51537 ; 7127555557
• MDR Report Key: 25535537
• Report Number: 1932668-2026-00002
• Device Sequence Number: 9359023
• Product Code: FPA
• UDI-Device Identifier: B144MPC1300
• UDI-Public: +B144MPC1300/$$529105203895
• Combination Product (Y/N): N
• PMA/510(K) Number: K925927
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: MPC-130
• Device Lot Number: 20389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 98469
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown