MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 30ML FLUSH, NEEDLELESS VALVE, 10ML SHEATH CONTAMINA; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number 42800-33

Device Problem Separation Problem (4043)

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

Event Date 12/23/2022

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation, pending investigation.

Event Description

The event involved a transpac it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve where it was reported there was a separation in the tubing.The reporter stated when doing rounds at 0900 a small amount of blood was noticed backing up in the umbilical arterial catheter (uac).The line was flushed and the connections were checked to see if anything was loose.The reporter stated blood started backing up even faster and small amounts of blood leaked onto the mattress.The line was turned off to the baby and it was found that the intravenous (iv) tubing going into the blue part of the transducer had come apart.The uac was removed without incident and a hematocrit and hemoglobin was drawn after the incident with no lowering of the hemoglobin.There was patient involvment, however no report of patient harm.

Manufacturer Narrative

Received one used partial.List #42800-33, transpac¿ it monitoring kit, 30ml flush, needleless valve, 10ml sheath contamination syringe; lot #12177833.One used.Manufacturer unknown, extension set w/ filter; lot #unknown.The reported complaint of separation was confirmed on the returned set.During visual inspection, the 4" pvc tubing was found separated from the transducer luer pocket.Insufficient uv adhesive coverage was observed on the tubing pocket.The uv adhesive was accumulated at the bond ring.The probable cause of the pvc tubing being separated had occurred due to insufficient uv adhesive coverage on the tubing during assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 30ML FLUSH, NEEDLELESS VALVE, 10ML SHEATH CONTAMINA
• 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: 16244836
• MDR Text Key: 308636426
• Report Number: 9617594-2023-00038
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709098053
• UDI-Public: (01)00887709098053(17)251101(10)12177833
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42800-33
• Device Catalogue Number: 42800-33
• Device Lot Number: 12177833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2022
• 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: UMBILICAL ARTERY CATHETER, UNK MFR