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

Catalog Number C1000

Device Problem No Flow (2991)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If the device is received a follow up report will be submitted.Additional reporter information: (b)(6).

Event Description

The event involved a clave® connector where the customer reported the last box received has a possible malformation inside with the plastic.The device won't flow on the intravenous (iv) pump and causes the pump to alarm as if there was an obstruction.The tubing is unable to be primed.The customer stated they would remove the clave and plug the line directly to the iv catheter and it would run.The clave was being used as a way to disconnect in the event of adverse reaction to the infusion.However, if the customer is having to remove it after starting the iv just to have it infuse, it defeats the purpose and is not easy to change out once running.There was patient involvement, however no patient harm.

• 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: 18403609
• MDR Text Key: 331547581
• Report Number: 9617594-2023-01199
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2023

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: C1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 INFUSION PUMP, UNK MFR; UNSPECIFIED INTRAVENOUS CATHETER, UNK MFR; UNSPECIFIED TUBING, UNK MFR