MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number MS933

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.No device history report (dhr) lot review was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.Additional contact: (b)(6).

Event Description

The event involved a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave®, clamp, rotating luer where the customer reported that one vial was broken open and all the liquid had leaked out.There was unknown patient involvement and unknown patient harm reported.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE®, CLAMP, ROTATING LUER
• 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: 18332417
• MDR Text Key: 330959463
• Report Number: 9617594-2023-01160
• 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: US
• PMA/PMN Number: K964435
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS933
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2023
• 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 VIAL, MFR UNK.