MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42800-39

Device Problems Disconnection (1171); Material Separation (1562)

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

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The event occurred on an unspecified date and involved a transpac¿ it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve.The reporter stated that a picu/nicu experienced a disconnect of the intravenous (iv) administration extension set at the bonding point on their transpac it transducer.There was no patient involvement or patient harm reported.

Manufacturer Narrative

The reported complaint of separation was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the pvc tubing was found separated from the transducer luer pocket.The pvc tubing was observed to be tacky.The probable cause of the pvc tubing being tacky was due to the tubing not being fully cured during assembly.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: 15805717
• MDR Text Key: 307166589
• Report Number: 9617594-2022-00302
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709098169
• UDI-Public: (01)00887709098169(17)250901(10)8602165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42800-39
• Device Catalogue Number: 42800-39
• Device Lot Number: 8602165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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