MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET¿ 24 INCH ARTERIAL PRESSURE TUBING, SAFESET¿ RESERVOIR AND BLOOD SAMPLING; CATHETER, CONTINUOUS FLUSH

Catalog Number 423280412

Device Problem Material Separation (1562)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however it has not yet been received.

Event Description

The event occurred around 0945 and involved a safeset¿ 24 inch arterial pressure tubing, safeset¿ reservoir and blood sampling port.A new arterial pressure line with safeset tubing was primed with heparinized normal saline and connected to the patient.At around 0945, the nurse found the tubing leaking as the safeset tubing had snapped between the tubing and the hub (not at the connection point).The patient lost approximately 10-20ml blood while actively receiving a blood transfusion of red blood cells.The nurse clamped both ends of the line, primed a new line and safeset, and connected it to the patient.There was no delay in the critical therapy.There was patient involvement, however no change in the patient's status was assessed afterwards, and no report of harm.

Manufacturer Narrative

The reported complaint cannot be confirmed.No product samples or videos were returned for investigation.However an image was provided by the customer showing the involved product and the assumed area of the defect.A failure mode could not be identified from the image provided by the customer.Without the return of the sample a probable cause could not be identified.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.Additional information: d9 - device available for evaluation and d9 - date returned to mfg null.

• Brand Name: SAFESET¿ 24 INCH ARTERIAL PRESSURE TUBING, SAFESET¿ RESERVOIR AND BLOOD SAMPLING
• 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. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14596639
• MDR Text Key: 301584188
• Report Number: 9617594-2022-00149
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00840619044244
• UDI-Public: (01)00840619044244(17)250301(10)5877906
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K932188
• 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,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 423280412
• Device Lot Number: 5877906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/29/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: HEPARINIZED NORMAL SALINE, MFR UNK.