MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 247 CM (97") EXT SET W/5 GANG STOPCOCK, 6 MICROCLAVE® CLEAR, 4 CLAVE® CLEAR, CHE; STOPCOCK, I.V. SET

Catalog Number 011-MC5006

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved a 247 cm (97") ext set w/5 gang stopcock, 6 microclave® clear, 4 clave® clear, check valve, rotating luer, yellow pur tubing.The following issue was reported by the customer: a leak of an unspecified drug/infusate was detected followed by a break at one of the valves.The device was connected to a patient (during an infusion) at the time of the incident.The leak was discovered when the manifold was removed from the manifold holder for a transfer.There was no unprotected chemo exposure.The leak was cleaned up as per the facility protocol, no specific kit used.The leak did not come in contact with a patient or healthcare professional.There was no adverse event or human harm.

Manufacturer Narrative

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

Manufacturer Narrative

A photo was provided by the customer where a broken microclave from the manifold was observed.No additional damage or anomalies were observed as a result of the photo review.One used sample item list #011-mc5006 was returned for evaluation.As received, the microclave was broken off from manifold.A plastic deformation and beach mark on the broken-off microclave was identified and confirmed.No additional damage or anomalies were confirmed.No mating device was returned for evaluation.The customer's complaint of cracks can be confirmed based on the physical sample evaluation, the probable cause is typical due to unintentional bending force applied during use.A device history record review could not be conducted because no lot number was identified.D9 - date returned to mfg 26jan2024.

• Brand Name: 247 CM (97") EXT SET W/5 GANG STOPCOCK, 6 MICROCLAVE® CLEAR, 4 CLAVE® CLEAR, CHE
• 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: 18499592
• MDR Text Key: 333111793
• Report Number: 9617594-2024-00026
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC5006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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 INFUSATE/SOLUTIUON, MFR UNK.