MAUDE Adverse Event Report: MOLDED PRODUCTS INC 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	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation included evaluation of customer-returned product, in-stock product from a different lot, review of production and assembly records, training records, raw material documentation, product design, and customer-supplied information.The review determined that the product was manufactured using approved materials and met applicable specifications.No deficiencies were identified with raw materials, equipment performance, design, or production documentation.However, the investigation confirmed that the product was not assembled in accordance with the established assembly protocol.Additionally, a lack of documented training specific to the assembly process was identified.The non-conformance was attributed to insufficient training and failure to adhere to the approved assembly protocol.Corrective actions have been identified to address training documentation requirements and to reinforce compliance with the established assembly procedures to prevent recurrence.
Event or Problem Description
Clinic personnel noted on (b)(6) 2025 while removing the see luer cap set mpc-130 from its bag, that the threaded sleeve was not engaged with the luer pin.The health worker set aside the part and obtained a new part.No direct patient involvement was noted.This event was reported to molded products 12/08/2025 an investigation was immediately opened.

• Brand Name: MPC-130
• Common Device Name: SEE LUER CAP SET
• Manufacturer (Section D): MOLDED PRODUCTS INC; 1812 industrial pkwy; harlan IA 51537
• Manufacturer (Section G): MOLDED PRODUCTS. INC; 1812 industrial pkwy; harlan IA 51537
• Manufacturer Contact: teresa wooster ; 1812 industrial pkwy; harlan, IA 51537 ; 8004358957
• MDR Report Key: 24318216
• Report Number: 1932668-2026-00001
• Device Sequence Number: 4837815
• Product Code: FPA
• UDI-Device Identifier: B144MPC1300
• UDI-Public: +B144MPC1300/$$529105203895
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K925927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace,Recall
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown