MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EMPTY PCA VIAL WITH INJECTOR; PUMP, INFUSION, PCA

Catalog Number	060210403
Medical Device Problem Codes	Particulates (1451); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an unspecified pca vial.The customer reported that they found numerous vials with particles in the packaging and in the vials themselves that were rejected at incoming inspection due to the particulates found.The customer did sent to a third-party lab for testing with results being cardboard, organic materials, and different colored fibers.There was no harm reported as a consequence of this event.
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.
Event or Problem Description
Additional information was received providing list number is 060210403.Some of the product was opened for a week, but majority were unopened.The particulate was noted first in the original container, all in the original container.The product was stored in the customers facility in the plastic bags in plastic totes, temperature mapped rooms per cgmp guidelines.The event occurred over the past year, initially during inspection of finished goods then was being checked upon opening.The customer further stated that the particulates were found in the empty units prior to production as well as in post production during visual inspection.The customer considers their testing complete by their customer (ourpharma llc) with findings of cardboard, organic materials and different colored fibers to be valid since these were found during visual testing on their site.There was no patient involvement and unknown human harm.

• Brand Name: EMPTY PCA VIAL WITH INJECTOR
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19629628
• Report Number: 9617594-2024-00839
• Device Sequence Number: 15178401
• Product Code: MEA
• UDI-Device Identifier: 10887787001904
• UDI-Public: (01)10887787001904(17)251001(10)34328R1
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K143612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 10/01/2025
• Device Catalogue Number: 060210403
• Device Lot Number: 34328R1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 09/20/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/26/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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