MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	852-011-46106-45
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
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
It was reported that a transpac iv monitoring kit, disposable transducer, 3ml squeeze flush macro drip was found to have "fluid leakage found from the connection site that should not be separable".The connection dislodged when the staff was examining the leakage.The leakage was observed during the first few minutes on the patient.The involved product was used in adult intensive care unit (aicu) / e2c2.There was patient involvement; however, no harm was reported.
Additional Manufacturer Narrative
The reported complaint of tubing separation was confirmed on the returned set.An image was provided by the customer indicating the area of the defect.During visual inspection, the pvc tubing was received separated from the drip chamber.When the tubing pocket was microscopically examined, insufficient solvent coverage appeared to be present on the tubing.The probable cause for the separation between pvc tubing and the drip chamber had occurred due to insufficient solvent coverage on the tubing during assembly.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Additional information: d9 - date returned to mfg: 8/8/2023.

• Brand Name: TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI
• 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: 17548797
• Report Number: 9617594-2023-00551
• Device Sequence Number: 17811566
• Product Code: DRS
• UDI-Device Identifier: 00840619097295
• UDI-Public: (01)00840619097295(17)251101(10)13457776
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 07/20/2023

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 Catalogue Number: 852-011-46106-45
• Device Lot Number: 13457776
• 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: 07/20/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID, UNK MFR
• Patient Sex: Unknown