MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EMPTY PCA VIAL WITH INJECTOR; PUMP, INFUSION, PCA

Catalog Number	060210421
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event occurred on unspecified dates and involved a empty pca vial with injector.The reporter stated that the vials had particulate matter or other defects.The process requires inspection of starting materials during different stages of material transfer.The event occurred over the course of months.The customer alleged particulates in the vial, in the packaging, and other generalized defects.It is unknown how many vials were alleged to have contamination within the vial; however, a total of 2000 were reported as defective for any of the aforementioned failure modes.There was no patient involvement and no adverse event.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e initial reporter (full) phone no information: (b)(6).
Additional Manufacturer Narrative
The complaint for vials had a particulate matter or other defects leading to them being rejected from use in production in sterile empty vial and injector, lot 20119r1 with list 060210421/material number f000205205 was investigated.The investigation included reviewing retain samples, batch records, historical investigations and complaints data.This investigation was reopened as samples were received on 10/25/2024.The reported defect for vials that had a particulate matter or other defects leading to them being rejected from use in production was present in the supplied returned complaint samples.Multiple particles were present in the blister packs containing sterile empty vial and injectors.All observed particles were outside the solution pathway of the vials.Tsr-126950 found 0 out of 52 vials and injectors inspected for lot 20119r1 with particulate in solution pathways.The reported defect was not present in the reserve samples.Consequently, this complaint is confirmed.The root cause is most likely process related.The probable root cause was determined to be presence of particulate is inherent to the environment during the packaging process of the pca sterile empty vials into blister packs.The complaint of vials that had a particulate matter or other defects leading to them being rejected from use in production for lot 20119r1 is considered an isolated occurrence as definitions for trending were not met.A batch record review was performed for lot 20119r1.The information contained in the executed batch record and laboratory test data was reviewed by product complaints personnel for issues during manufacturing that could result in a complaint of this nature.No issues that could have contributed to the complaint defect were identified.D9 device returned to manufacturer on 10/10/2024.

• Brand Name: EMPTY PCA VIAL WITH INJECTOR
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20433294
• Report Number: 9615050-2024-00754
• Device Sequence Number: 7608486
• Product Code: MEA
• UDI-Device Identifier: 10887787001904
• UDI-Public: (01)10887787001904(17)230801(10)20119R1
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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: 08/01/2023
• Device Catalogue Number: 060210421
• Device Lot Number: 20119R1
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• 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