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

Catalog Number	11956
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a clave¿ connector.The customer reported difficulties/malfunctions with possible lot numbers #13906163 and #13869268.An emergency room (er) nurse reported that when the clave was hooked up to a stopcock on a syringe, it wasn't allowing him to draw back the syringe.The nurse stated that was almost like it was creating a vacuum and not allowing any control over pushing the syringe with an unspecified medication that needs to be pushed over a certain amount of time.The nurse was able to figure out that if he puts the clave onto the stopcock at just the right angle then the device will allow him to do what he needs to do correctly.There was no report of human harm associated with this complaint/event.
Additional Manufacturer Narrative
The device is not available to be returned for evaluation.Without the return of the sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.If additional information or if a device later becomes available, supplemental emdr(s) will be submitted at that time.

• 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: 19817437
• Report Number: 9617594-2024-00932
• Device Sequence Number: 8780946
• Product Code: FPA
• UDI-Device Identifier: 00887709042193
• UDI-Public: (01)00887709042193
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: 11956
• Device Lot Number: PLOTS
• 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: 06/27/2024
• Initial Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 MEDICATION. MFR UNK.; UNSPECIFIED SYRINGE, MFR UNK.
• Patient Sex: Unknown