MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®; SYRINGE, PISTON

Catalog Number	CH3340
Medical Device Problem Codes	Fluid/Blood Leak (1250); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a bag spike w/clave® additive port, clave®.It was reported that fluid was prevented from passing through when attaching hazardous a infusions to the iv set when connected.There was also possible leakage upon disconnection.The spiros ports were stuck open on the ch3340 (either spiros port) after disconnecting.The internal stopper appears to be turned/misaligned and it doesn¿t spring back to close the port.Their process for infusions is sending the iv bag with the ch3340 attached from pharmacy.Nursing then adds a ch3034 bag spike adapter onto the spike of a regular iv set and adds a spinning spiros closed male luer adapter ch2000s to the luer side of the iv set.They connect the ch3034 spiros to the in-line bag spike and then attach the spinning spiros to the additive port on the bag to circle prime.They have had multiples issues with leaks from either of the spiros ports on the ch3340 that were not reactivating when disconnecting causing unspecified chemotherapy to spill.In most of these situations, the fluid doesn¿t pass through to the line, so the nurse goes to check or detach from the bag spike spilling after disconnection, and additionally they have had some spills from the additive port on the spike when disconnecting the patient end of the line just prior to administration.There was no human harm.This emdr reflects the first of two similar occurrences.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If a return or any additional information is later received, then a supplemental emdr will be submitted at that time.
Additional Manufacturer Narrative
A photo was provided showing a stick down on the clave after being connected to by a spiros.The reported complaint can be confirmed on the ch3340.The probable cause is due to a molding defect.The device history lot number was reviewed, and no nonconformities were found that would have led to the reported complaint.Corrective actions are in process.

• Brand Name: BAG SPIKE W/CLAVE® ADDITIVE PORT, CLAVE®
• Common Device Name: SYRINGE, PISTON
• 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: 21912673
• Report Number: 9617594-2025-00842
• Device Sequence Number: 7266846
• Product Code: FMF
• UDI-Device Identifier: 00840619056216
• UDI-Public: (01)00840619056216(17)291001(10)14163785
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K080989
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: CH3340
• Device Lot Number: 14163785
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CH3034 5"(13CM)BAGSPIKEADAPTERW/SPIROS, MFR UNK.; SPINNING SPIROS¿REFCH2000SCLOSEDMALELUER MFR UNK.; UNSPECIFIED HAZARDOUS CHEMOTHERAPY, MFR UNK.; UNSPECIFIED IV SET, MFR UNK.
• Patient Sex: Unknown