MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED SET EXT DISP ST 4GANG 14IN BASEPLATE CLAMP; STOPCOCK, I.V. SET

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/17/2024

Event Type  malfunction  

Event Description

The event involved an unspecified set ext disp st 4gang 14in baseplate clamp a cat # provided i88b55005 to their distributor cardinal health.The customer reported that the blue port of manifold extension set was leaking.The complaint was noticed prior to use.The problem occurred for the first time.The customer also added that the complaint was noticed during and after use.There was unknown patient involvement, and no patient injury was reported.This is the first of two.

Manufacturer Narrative

E1 - initial reporter phone has an extension # of (b)(6).The device is available for investigation- it has not been received.Additional contact: (b)(4), territory manager cardinal health 1000 tesma way vaughan, on l4k 5r8 canada (b)(4).

• Brand Name: UNSPECIFIED SET EXT DISP ST 4GANG 14IN BASEPLATE CLAMP
• Type of Device: STOPCOCK, I.V. SET
• 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: 19095913
• MDR Text Key: 340807555
• Report Number: 9617594-2024-00410
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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