MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46104-07
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Gcm received an email on 24-may-2024 from icu medical critical care specialist forwarding a complaint from (b)(6) a clinical value analyst of (b)(6) hospital regarding a monitoring kit w/tp4, 30 ml squeeze flush and needleless valve with item number 46104 and lot number 11376856.It was stated in the report that when priming neonatal a-line transducer, the stopcock at the end of the transducer line came apart and fell back onto sterile field, the tubing came apart from the stopcock.Device was not reprocessed and reused on a newborn male patient.The event occurred on 09-may-2024 during priming.There was patient involvement, unknown patient harm and unknown delay in therapy.Rmontes 27-may-2024 update: gcm received an email on 29-may-2024 from (b)(6) stating that there was no medication involved, no patient harm and no delay in therapy.Rmontes 29-may-2024.
Additional Manufacturer Narrative
The reported complaint of tubing separation was confirmed on the returned set.During visual inspection, the 28" pressure tubing was received separated from the male luer.When the end of the tubing was microscopically examined, insufficient adhesive coverage was observed.The probable cause of insufficient adhesive coverage on the pressure tubing had occurred due to an error during assembly.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: MONITORING KIT W/TP4, 30 ML SQUEEZE FLUSH AND NEEDLELESS VALVE
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19813224
• Report Number: 9617594-2024-00924
• Device Sequence Number: 8589715
• Product Code: DRS
• UDI-Device Identifier: 00887709060623
• UDI-Public: (01)00887709060623(17)251101(10)11376856
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2024

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 Expiration Date: 11/01/2025
• Device Catalogue Number: 46104-07
• Device Lot Number: 11376856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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