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

Catalog Number 011-C1000

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it has not yet been received.

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
• Type of Device: 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
• MDR Text Key: 328512933
• Report Number: 9617594-2023-01001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• UDI-Public: (01)00840619000011(17)280301(10)13576927
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 011-C1000
• Device Lot Number: 13576927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED SYRINGE, MFR UNK