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
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, pending investigation.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9617594-2023-00038
• Device Sequence Number: 6313058
• Product Code: DRS
• UDI-Device Identifier: 00887709098053
• UDI-Public: (01)00887709098053(17)251101(10)12177833
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UMBILICAL ARTERY CATHETER, UNK MFR
• Patient Sex: Unknown