MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VAL; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42800-37
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a transpac¿ it trifurcated monitoring kit, 84" safeset reservoir, 2 needleless valves, 3ml flush devices, macro drip pole mount.The reporter stated when using device they were unable to remove the monitoring cord and it breaks off when they push the small clip down.There was unknown patient involvement and no report of patient harm.
Additional Manufacturer Narrative
The device is available for evaluation, however has not been received.
Additional Manufacturer Narrative
The complaint of difficulty to remove/open on the 42800-37 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) for lot 13490298 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 84" SAFESET RESERVOIR, 2 NEEDLELESS VAL
• 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: 16743937
• Report Number: 9617594-2023-00140
• Device Sequence Number: 6445692
• Product Code: DRS
• UDI-Device Identifier: 00887709098091
• UDI-Public: (01)00887709098091(17)251201(10)13490298
• 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): 03/24/2023

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: 12/01/2025
• Device Model Number: 42800-37
• Device Catalogue Number: 42800-37
• Device Lot Number: 13490298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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