MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	C1000
Medical Device Problem Codes	No Flow (2991); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Event or Problem Description
An event involving a clave connector reported that the clave inner plastic piece does not compress to allow flow of intravenous (iv) fluids.There was unknown patient involvement and unknown harm/adverse event reported.
Additional Manufacturer Narrative
Additional information can be found in b5.Note: because the additional information indicates that the issue occurred during priming and prior to patient connection, the annex a code was updated to a25.Corrected information can be found in section d10 concomitant products and h6 component code.
Event or Problem Description
Additional information was received on 03mar2026 as follows: the customer's reported issue occurred during priming.Although there was patient involvement, there was no harm.
Event or Problem Description
The event of 1/21/2026 was determined not to meet the manufacturer¿s reportability criteria because the device did not cause or contribute to a death or serious injury, nor did the malfunction present a risk that would be likely to cause or contribute to a death or serious injury if it were to recur.
Additional Manufacturer Narrative
Correction b5: the event of 1/21/2026 was determined not to meet the manufacturer¿s reportability criteria because the device did not cause or contribute to a death or serious injury, nor did the malfunction present a risk that would be likely to cause or contribute to a death or serious injury if it were to recur.

• Brand Name: CLAVE¿ CONNECTOR
• 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: 24494244
• Report Number: 9617594-2026-00214
• Device Sequence Number: 10638182
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: (01)00840619069896(17)300801(10)14529836
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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 Catalogue Number: C1000
• Device Lot Number: 14529836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/03/2026; 03/03/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID/INFUSATE, MFR UNK.
• Patient Sex: Unknown