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

Catalog Number	B3300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved a clave¿ neutral connector where the customer reported that when collecting blood, the hub was leaking with draw backs.Additional information was received stating that the neutral connector was attached to the contrast tubing from the injector and appeared fine.Once the technologist began the iv injection and there was around 75cc of iv contrast injected, the injector stalled and gave an error; contrast leaked from the attached hub and both the nurse and the technician noticed the white portion in the inside of the hub retreated inwards.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One hundred new list# b3300, clave¿ neutral connector were returned for evaluation.As received, no anomalies or damage were confirmed.No mating device was returned for evaluation.Based on the binomial stages sampling to represent the lot population 35 samples were taken and were one time activated with a 10 ml bd syringe and functionally leak tested, after the test no leak was confirmed.Complaint of the hub leaking with draw backs cannot be confirmed or replicated.Without the return of the actual used device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 10apr2025.Corrected information can be found in concomitant products and e4.

• 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: 21699857
• Report Number: 9617594-2025-00560
• Device Sequence Number: 15401119
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: (01)00840619045593(17)290801(10)14096159
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• 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): 06/02/2025

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: B3300
• Device Lot Number: 14096159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: UNSPECIFIED CONTRAST INFUSATE, MFR UNK.; UNSPECIFIED CONTRAST TUBING, MFR UNK.; UNSPECIFIED INJECTOR, MFR UNK.
• Patient Sex: Unknown