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

Catalog Number	011-C1000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a clave¿ connector in which the customer reported that there appears to be a piece of plastic that has broken off the clave connector when being connected to the syringe, and got caught at the end of the syringe which was stopping the liquid from being dispensed.The syringe was disposed of.The clave connector is stored on the customer trolleys in the chemotherapy department like their other consumables.No defects were noted before the product was opened.There was unknown patient involvement, however, harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it has not yet been received.
Additional Manufacturer Narrative
No product samples were returned for investigation, however, a series of photographs were returned showing and confirming the internal clave spike tips broken off inside the male luers of glass syringes.The probable cause of this type of damage is typical of access with an incompatible mating device during use.The directions for use states: the clave connector is compatible with luers with an internal diameter (id) between 1,55 mm and 2,8 mm.The lot history review was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• 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: 18166135
• Report Number: 9617594-2023-01001
• Device Sequence Number: 17777559
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• UDI-Public: (01)00840619000011(17)280301(10)13576927
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 011-C1000
• Device Lot Number: 13576927
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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 SYRINGE, MFR UNK
• Patient Sex: Unknown