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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation however investigation is not yet complete.
Event or Problem Description
The event involved a monitoring kit w/tp4, 30 ml squeeze flush and needleless valve where the customer reported that blood sample draw stopcock on arterial line setup leaking when flushed through.The connection was tightened and was able to flush through without leaking.Leaking occurred again around 2200 when flushing through, and connections were tight.There was no leaking unless flushing through line.Line was also difficult to flush.The customer ordered a new a-line fluid bag and was able to change over setup at 0300.Once setup was changed, there were no issues with flushing/drawing or leaking.The customer stated that the device was not reprocessed and reused on a 3-week female patient.The event occurred on 22-may-2024.There was patient involvement, no patient harm and unknown delay in therapy.The customer stated that there was no medication involved and no delay in therapy.No harm was reported as a consequence of this event.
Additional Manufacturer Narrative
The device was received for evaluation and it was visually and functionally tested.The reported complaint of leakage was not confirmed.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, no leaks were observed.The product had performed per the specifications.Lot history review could not be conducted because no lot number(s) was/were identified.

• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19580162
• Report Number: 9617594-2024-00789
• Device Sequence Number: 3340499
• Product Code: DRS
• UDI-Device Identifier: 00887709060623
• UDI-Public: (01)00887709060623
• 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): 08/08/2024

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: 46104-07
• Device Lot Number: UNKNOWN
• 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
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 21 DA
• Patient Sex: Female