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.

Manufacturer Narrative

Reveived one used partial.List #011-46103-90, safeset¿ - transpac® it w/03 ml reservoir and needleless valve, red stripe tubing, with velcro arm strap, patient mount; lot #13534687.One used.Unknown manufacturer, unknown tubing; lot #unknown.The reported complaint of separation was confirmed.During visual inspection, only the rotating male luer connecting to the unknown tubing was received for evaluation.The separated tubing from the rotating male luer was not received for evaluation.It is unknown how and when the tubing went separated from the rotating male luer.Without the return of the entire set, which was connected to the rotating male luer, a probable cause could not be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 device received on 8/23/2023.

• 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,Followup
• Report Date: 05/29/2024

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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