MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 46115-68

Device Problems Crack (1135); Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The event occurred on unknown date involving a transpac® iv monitoring kit, 84", disposable transducer, 3 ml squeeze flush device, macrodrip un-bonded where the customer reported that while in the patient room, they discovered the arterial line was bleeding back.Upon further inspection, there was a hole/crack in arterial line tubing/stopcock where blood was ¿spraying out¿.It was further stated that the bleeding was quickly stopped, and tubing was changed.There was patient involvement and unknown human, or adverse event reported.

Manufacturer Narrative

The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If additional information becomes available a supplemental report will be submitted.

• Brand Name: TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVI
• Type of Device: 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: 18800704
• MDR Text Key: 336962924
• Report Number: 9617594-2024-00211
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46115-68
• Device Lot Number: 13818052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1