MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED EMPTY PCA VIAL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	060210421
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 on an unspecified date involved unspecified pca vials that had foreign matter inside.It was reported that the customer was finding numerous vials with particles in the packaging and in the vials themselves.They had in the recent past had complete batches rejected due to the particulates found while visually inspected.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
Customer reported lot# 34226r1, but this was not found in the icu database.It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.
Additional Manufacturer Narrative
Additional information provided in d4.
Additional Manufacturer Narrative
Eighteen (18) photos were provided by the customer for evaluation.The provided photos did not confirm the presence of particulate in vials (inside fluid path) labeled with lot 34328r1 as no product lot number was visible in the photos.Fifty-five (55) vials with injectors were received for evaluation and none of the 55 units contained particulate in the solution pathway.One hundred and fifty (150) retained samples from lot 34328r1 were visually inspected for particles in packaging and all other defects.There was no evidence of the complaint condition, or any other defects found in the 150 retained samples inspected.A batch record review for lot 34328r1 was conducted and no issues that could have contributed to the complaint defect of foreign material were identified.Checks and challenges are in place to detect defective units.

• Brand Name: UNSPECIFIED EMPTY PCA VIAL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19630368
• Report Number: 9615050-2024-00505
• Device Sequence Number: 15227086
• Product Code: FPA
• UDI-Device Identifier: 10887787001904
• UDI-Public: (01)10887787001904(17)251001(10)34226R1
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 06/19/2025

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 Expiration Date: 10/01/2025
• Device Catalogue Number: 060210421
• Device Lot Number: 34226R1
• 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: 09/25/2024; 05/23/2025
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 10/23/2024; 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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