MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET¿ 84" ARTERIAL PRESSURE TUBING, SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING P; CATHETER, CONTINUOUS FLUSH

Catalog Number 423220402

Device Problem Material Separation (1562)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

The event involved a 84" arterial pressure tubing, safeset¿ reservoir and 2 blood sampling ports in which the customer reported that the a-line tubing easily disconnected from the 1st sample port coming from the patient.There was blood loss/bleed back amounting to 10ml and the tubing was replaced.The nurse was flushing the a-line and had noticed it before any harm was caused to the patient.This is report 1 of 2.

Manufacturer Narrative

No samples or videos were returned for evaluation.However, an image was provided by the customer showing the arterial line separated from the safeset port.Without the return of the reported sample a probable cause could not be identified.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.

• Brand Name: SAFESET¿ 84" ARTERIAL PRESSURE TUBING, SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING P
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa.
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16004666
• MDR Text Key: 308496353
• Report Number: 9617594-2022-00326
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 423220402
• Device Lot Number: 5866745
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• 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