MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426460406
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D1 brand name: transpac® iv monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84" tubing, disposable transducer, 3 ml squeeze flush, macrodrip (pole mount) d4.And h4.Because lot number is unknown, the expiration and manufacture dates are unknown.
Event or Problem Description
An event involving a transpac® iv monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84" tubing, disposable transducer, 3 ml squeeze flush, macrodrip (pole mount) experienced breakage.It was reported that the customer had a faulty tubing.The event was noted on 22-jul-2024.There was unknown patient involvement, and unknown human harm.It was reported that the product had a broken art line kit.Update: it was noted that there were no visible defects seen prior to the brakeage.There was patient involvement, no human harm, and there was delay in therapy.
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 safeset port was received separated from the 25" pressure tubing.When the end of the tubing was microscopically examined, insufficient solvent coverage was observed.The probable cause of the pressure tubing separation had occurred due to insufficient solvent coverage on the tubing during assembly in manufacturing.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20017343
• Report Number: 9617594-2024-01166
• Device Sequence Number: 8590697
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: 00840619028053
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• 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): 10/08/2024

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 Catalogue Number: 426460406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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