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

Model Number	46104-07
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The incident involved a monitoring kit w/tp4, 30 ml squeeze flush and needleless valve.It was reported that the pressure tubing broke in half.It was mentioned that the registered nurse was having difficulty getting an arterial waveform on the bedside monitor so they checked the set and noticed the broken tubing.The mating device was an alaris infusion and the infusion was 0.9 normal saline (ns).The event happened during infusion.The product was not reprocessed or re-sterilized prior to use.There was patient involvement and no human harm.
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 tubing pocket was microscopically examined, insufficient adhesive coverage was observed on the tubing pocket.The probable cause of insufficient adhesive coverage on the pressure tubing had occurred due to an error during assembly at ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9: device returned to mfr on 11-jul-2023.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17305340
• Report Number: 9617594-2023-00353
• Device Sequence Number: 6684515
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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: 11/01/2025
• Device Model Number: 46104-07
• Device Catalogue Number: 46104-07
• Device Lot Number: 11376856
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.9 NORMAL SALINE, MFR UNK; ALARIS INFUSION SET
• Patient Sex: Unknown