MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET¿ - TRANSPAC® IT W/03 ML RESERVOIR AND NEEDLELESS VALVE, RED STRIPE TUBIN; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46103-90

Device Problem Separation Problem (4043)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a safeset transpac® it w/03 ml reservoir and needleless valve, red stripe tubing, with velcro arm strap, patient mount device where it was reported the glue that sticks the barrel to the arterial line transducer came undone and the patient lost blood.There was patient involvement and unknown patient harm.

Manufacturer Narrative

The device is available for evaluation, however has not been received.

• Brand Name: SAFESET¿ - TRANSPAC® IT W/03 ML RESERVOIR AND NEEDLELESS VALVE, RED STRIPE TUBIN
• 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: 17644682
• MDR Text Key: 322209292
• Report Number: 9617594-2023-00604
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619043124
• UDI-Public: (01)00840619043124(17)260201(10)13534687
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46103-90
• Device Lot Number: 13534687
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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