MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AMICUS DOUBLE NEEDLE ADVANCED KIT WITH PLATELET ADDITIVE SOLUTION CONNECTOR; FOR COLLECTION OF PLATELETS WITH OPTIONAL PLASMA. FOR PLATELET STORAGE IN PLASMA

Model Number	4R2352
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Fresenius kabi haina investigation conclusion: no sample or image available for analysis.Although there is no image or sample available, the complaint is confirmed due to the criticality of the defect and an internal investigation was opened to address this issue.A comprehensive trend analysis of bioburden testing data collected between (b)(6) 2024 and (b)(6) 2025 demonstrated that no out of limit {ool) results were identified for the amicus and product in process (pip) product categories.A microorganism trend analysis was conducted from (b)(6) 2025.No staphylococcus species were detected in the bioburden testing of either amicus or product in process {pip) product categories.However, during the environmental and water monitoring performed within the same period, staphylococcus epidermidis was identified in microbiological surface and water samples from clean room #1 on december 2024 and jun 2025.Therefore, the customer complaint is confirmed.To ensure a thorough analysis, an internal investigation has been initiated to address this defect and identify any potential root causes and corrective actions.To assure the integrity of the kit, the following controls are established at the manufacturing site 1) microbiology monitoring, 2) product e-beam sterilization, 3) in process sampling quality inspection, 4) post sterilization sampling final inspection, 5) the first piece inspection will be performed to the first final assembled kit manufactured per shift.This kit will be submitted to visual inspection as per the classification of defects included in this specification and as per the applicable drawing, 6) 100% visual inspection is performed in manufacturing line.All complaints are captured in tracking and trending and reviewed monthly to determine if additional investigation is required for further root cause analysis and any corrective actions.No action required at this time.No adverse trend was observed in the last product review meeting performed before this complaint was received.Fresenius kabi maricao conclusion: the species staphylococcus epidermidis and staphylococcus caprae have been recovered at the maricao plant during the environmental monitoring period from january 2024 to july 2025.S.Epidermidis is among the most frequently recovered microorganisms, with a stable presence primarily associated with surface tests.In the filling 4 department, where the lots related to the complaint were manufactured, s.Epidermidis was recovered and all recoveries were associated with surface tests.S.Caprae was recovered primarily associated with room air tests, indicating occasional presence rather than persistence.In the filling 4 department, s.Caprae was recovered and all recoveries were associated with surface and air tests.According to microbiological classification criteria, s.Epidermidis is considered a resident organism, while s.Caprae is considered transient under current evaluation criteria.Both species are gram-positive, coagulase-negative cocci, sensitive to the disinfectants used at the site, and have not been associated with product quality deviations or contamination events.Therefore, they are considered relevant but nondominant environmental components, with no direct impact on product quality.Their recovery from areas such as surfaces and air is expected in controlled environments, particularly in zones with operational activity.However, neither s.Epidermidis nor s.Caprae was recovered from manufacturing areas where the product could be directly exposed, nor were they identified in the products associated with the complaint.Both microorganisms are highly susceptible to the disinfectants used at the maricao site and to elevated temperatures.All products manufactured at the maricao site undergo terminal heat sterilization cycles that ensure a sterility assurance level (sal) of 10-6.The d-values for these organisms confirm they cannot survive the validated sterilization cycles at the site.For a contaminated product at the hospital to have originated from maricao, the following conditions must be met 1) the bacteria must be present in the maricao clean room during the manufacturing process (neither organism was identified in clean room areas during product manufacturing), 2) it must be able to enter the product (neither organism was identified as part of the bioburden process), 3) it must survive thermal steam sterilization (d-values confirm survival is not possible).After a comprehensive review of batch records and retained sample evaluations, no evidence was found to indicate that the reported contamination originated from the maricao site.
Event or Problem Description
Per the arc capa quality engineer, supplier quality: we logged a new nsepd this afternoon for a positive bact case.Staphylococcus epidermidis and staphylococcus caprae were isolated as well as noted three different colony morphologies.The involved donation was in-house (not distributed) collected on (b)(6) 2025.Original bottles summarized below: gram stain aerobic culture medium anaerobic culture medium bpa bottle: no organisms seen (bpa) culture - staphylococcus epidermidis three different colony morphologies culture - no growth bpn bottle: no organisms seen (bpa) culture - staphylococcus caprae staphylococcus epidermidis culture - no growth.Reculture bottles summarized below: gram stain aerobic culture medium anaerobic culture medium bpa bottle: no organisms seen updated to gpc in clusters (bpa) culture - staphylococcus epidermidis.Three different colony morphologies culture - no growth bpn bottle: no organisms seen (bpa) culture - staphylococcus epidermidis three different colony morphologies culture - no growth.Fresenius kabi product used for the donation: amicus kit lot number fa25h11191, intersol lot number fm25f13043.There are no samples available.Fresenius kabi has completed the following investigations.All batch reviews related to this incident were performed with satisfactory results.No issues were identified during the batch reviews that could contribute to the reported issue.All retention sample reviews related to this incident were performed with satisfactory results.No issues were identified during the retention sample reviews that could contribute to the reported issue.No additional positive bact complaints have been received for the reported amicus kit batch fa25h11191.Based on this analysis, fresenius kabi did not identify any evidence indicating that the reported contamination originated from fresenius kabi product or fresenius kabi manufacturing facilities.We are reporting conservatively based on the nature of the reported complaint.

• Brand Name: AMICUS DOUBLE NEEDLE ADVANCED KIT WITH PLATELET ADDITIVE SOLUTION CONNECTOR
• Common Device Name: FOR COLLECTION OF PLATELETS WITH OPTIONAL PLASMA. FOR PLATELET STORAGE IN PLASMA
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502913
• MDR Report Key: 23771118
• Report Number: 3004548776-2025-00605
• Device Sequence Number: 21490571
• Product Code: GKT
• UDI-Device Identifier: 00810020440713
• UDI-Public: 00810020440713
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: BK960005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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 Model Number: 4R2352
• Device Catalogue Number: 4R2352
• Device Lot Number: FA25H11191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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