MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING SPIKE KIT W/SAFESET¿ RESERVOIR, 03 ML SQUEEZE FLUSH DEVI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 081-46115-19

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Testing and investigation was performed and found leakage between the 1-way stopcock and the female luer.The probable cause of the leak was the hard to hard solvent bonded connection not being fully engaged during the manual assembly process, leading to a channel leak.

Event Description

The customer reported that transpac iv monitoring spike kit was leaking from the connection point.This was detected prior to patient use.

• Brand Name: TRANSPAC® IV MONITORING SPIKE KIT W/SAFESET¿ RESERVOIR, 03 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: patricia sharpe-gregg, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8251064
• MDR Text Key: 134304173
• Report Number: 9617594-2019-00013
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619093891
• UDI-Public: (01)00840619093891(17)191101(10)3340408
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2018

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: 11/01/2019
• Device Catalogue Number: 081-46115-19
• Device Lot Number: 3340408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2018
• 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