MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NOT PROVIDED; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number NOT PROVIDED

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

Patient Problem Awareness during Anaesthesia (1707)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.If additional information is received, supplemental reports will be submitted.

Event Description

User facility medwatch# (b)(4) received on 13-nov-2019 which stated the following " pt suddenly waking up to extubate self during shift change ¿ grabbed onto endotracheal tube (et) tube and nearly extubated self.Night shift (noc) rn happened to still be at desk and saw this happen, and was able to run in and restrain patient.Propofol tubing was found to be laying in bed with large wet spot under blankets.On closer examination, it was found that the blue clave on the iv extension set was broken in half; with one half wedged in the iv tubing, and the other end remaining on the extension set in broken pieces.Immediately clamped tubing and changed; sedation restarted and patient resedated within a few minutes." the event occurred on an unknown date in (b)(6) 2019.No additional information was provided.

• Brand Name: NOT PROVIDED
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9370560
• MDR Text Key: 219489812
• Report Number: 9617594-2019-00405
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NOT PROVIDED
• Device Lot Number: NOT PROVIDED
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• 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