MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 72" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42801-04
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, however it has not yet been received.
Event or Problem Description
The event involved a transpac it monitoring kit, 72" pressure tubing, 3ml flush device, un-bonded macrodrip and occurred at 12:00 pm that the customer reported when placing the priming pressure tubing in reach of the provider so that it could be connected to the arterial catheter, the tubing's last 14 inch end piece fell off onto the floor.The event occurred during priming, was in use for 5 minutes, and someone became aware of the issue through direct visualization.It is reported that this is not a bonding issue and the male/female part is not bonded, but this involves the male connection piece, itself, to detach.Additionally, the customer reported the tubing¿s end has a female adapter on the end and the tubing attached at the male connection is not supposed to come apart and that end has a sticky substance on it.No medication being used with the product.There was no patient involvement and no report of harm.
Additional Manufacturer Narrative
Received one used list #42801-04, transpac¿ it monitoring kit, 72" pressure tubing, 3ml flush device, un-bonded macrodrip; lot #4475360 on november 30, 2021 for evaluation.The reported complaint of tubing end piece falls off was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the 60" pressure tubing was received separated from the male luer.The pressure tubing was found tacky at the bond site.The separation of the bond was due to the pressure tubing being tacky.The probable cause of the pressure tubing being tacky is due to the uv adhesive on the tubing not being fully cured during assembly process.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 72" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA
• 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: 12857255
• Report Number: 9617594-2021-00300
• Device Sequence Number: 20122771
• Product Code: DRS
• UDI-Device Identifier: 00887709120662
• UDI-Public: (01)00887709120662(17)221101(10)4475360
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 11/10/2021

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: 11/01/2022
• Device Model Number: 42801-04
• Device Catalogue Number: 42801-04
• Device Lot Number: 4475360
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2019
• 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