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

Catalog Number	12568
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one (1) new.List #12568, clave¿ neutral connector with one (1) used.List #12568, clave¿ neutral connector connected to one (1) used.List #unknown, extension set for inspection.One (1) clave had been broken off the end of the extension set on the male luer side.The male luer was broken and stuck inside the clave.The clave and male luer showed some marks that suggested a bending force was applied.The samples were leak tested per product specification.Leakage was observed on one (1) used clave.No leakage observed on one (1) new clave.The complaint of broken clave and leakage can be confirmed on one (1) sample.The probable cause is due to an unintentional bending force applied during use.The complaint cannot be replicated or confirmed on one (1) sample.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Two parts of a clave¿ neutral connector reportedly snapped and started leaking the patient's unspecified drug during an infusion.There was no adverse event and no delay in therapy.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.

• Brand Name: CLAVE¿ NEUTRAL 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: 22729483
• Report Number: 9617594-2025-01625
• Device Sequence Number: 8884638
• Product Code: FPA
• UDI-Device Identifier: 00887709042377
• UDI-Public: 00887709042377
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2025

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: 12568
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/30/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DRUG/INFUSATE, MRF UNK
• Patient Sex: Unknown