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
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem 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.
Additional 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
• 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: 15805717
• Report Number: 9617594-2022-00302
• Device Sequence Number: 5402011
• Product Code: DRS
• UDI-Device Identifier: 00887709098169
• UDI-Public: (01)00887709098169(17)250901(10)8602165
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Patient Sex: Unknown