MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3955
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event occurred on an unspecified date(s) between late april through may and involved a chemoclave¿ bag spike with additive port, chemoclave¿ where the customer reported that there have been events of leaking.The customer stated that the leakage was noted at connection point of blue port and white body of chemoclave and that the unspecified chemotherapy administration was delayed.Although there was patient involvement, harm was not reported as a consequence or the event(s).
Additional Manufacturer Narrative
A photo was returned showing the ch3955 with the distal chemoclave circled.There was no leakage observed.Received two new ch3955 chemoclave bag spikes with additive port for inspection.No defects or anomalies noted.Each ch3955 was leak tested per product specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed.The device history report (dhr) was reviewed and no relevant nonconformities were found that would have led to the reported complaint.

• Brand Name: CHEMOCLAVE¿ BAG SPIKE WITH ADDITIVE PORT, CHEMOCLAVE¿
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22294512
• Report Number: 9617594-2025-01299
• Device Sequence Number: 8271280
• Product Code: FPA
• UDI-Device Identifier: 00887709098305
• UDI-Public: (01)00887709098305
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• 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): 06/23/2025

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 Catalogue Number: CH3955
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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