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 Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date involving a empty pca vial with injector where the customer stated that they are finding numerous vials with particles in packaging and inside the vials.The particulates found in the empty units prior to production as well as in post-production during visual inspection.They consider the testing completed by 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 no adverse reaction or need for medical intervention.
Additional Manufacturer Narrative
The device is reported to be available for evaluation, however, investigation is not yet complete.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19982451
• Report Number: 9617594-2024-01136
• Device Sequence Number: 11453157
• Product Code: MEA
• UDI-Device Identifier: 10887787001904
• UDI-Public: (01)10887787001904(17)230101(10)13027R1
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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: 01/01/2023
• Device Catalogue Number: 060210403
• Device Lot Number: 13027R1
• 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: 07/15/2024
• Initial Report FDA Received Date: 08/14/2024
• 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