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 Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event occurred on an unspecified date involved a safeset¿ - transpac® it w/03 ml reservoir and needleless valve, red stripe tubing, with velcro arm strap, patient mount.The customer reported that the glue to the hub underneath the stat lock came undone, causing the patient to bleed.There was no report of harm and there were no other details provided pertaining to clinical impact to the patient.

Manufacturer Narrative

The customer's complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record was reviewed and no non-conformities were found that would have led to the reported complaint.

• 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: 17564611
• MDR Text Key: 321775744
• Report Number: 9617594-2023-00560
• 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: K052828
• 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,Followup
• Report Date: 03/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-46103-90
• Device Lot Number: 13534687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/12/2024
• 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