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 TUBING; SAFESET¿ - TRANSPAC® IT

Model Number 011-46103-90

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

One (1) used, list # 011-46103-90, safeset¿ - transpac, lot# 3588266 was received for evaluation.As received, the 2" red stripe pressure tubing was found to be separated from the winged female luer.Uv adhesive was observed on the end of the tubing and in the tubing pocket of the female luer; however, the uv adhesive was tacky and appears to not be fully cured.A device history record (dhr) review was completed and no non conformities were noted.The probable cause of the failure appears to be that the uv adhesive at the bond between the arterial pressure tubing and female luer was not fully cured.

Event Description

The event involved a safeset¿ - transpac® it w/03 ml reservoir and needleless valve, red stripe tubing, with velcro arm strap, patient mount, that the customer reported that during out of package, the device came adrift from the line between the syringe and three way sample tap.It was also reported that the tubing fell out of the connector that screws onto the bottom of the syringe.The device was changed out with no further problems encountered.There was no adverse event and no delay in critical therapy reported.

• Brand Name: SAFESET -TRANSPAC IT W/03 ML RESERVOIR AND NEEDLELESS VALVE, RED STRIPE TUBING
• Type of Device: SAFESET¿ - TRANSPAC® IT
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• Manufacturer (Section G): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• Manufacturer Contact: christopher zanoni ; 600 n. field drive, bldg h2-2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 7686754
• MDR Text Key: 114027515
• Report Number: 9617594-2018-00041
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619043124
• UDI-Public: 840619043124
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/24/2018

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 Expiration Date: 01/01/2021
• Device Model Number: 011-46103-90
• Device Catalogue Number: 011-46103-90
• Device Lot Number: 3588266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2018
• Initial Date FDA Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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