MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46106-74

Device Problems Break (1069); Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

The reported complaint involved a transpac® iv w/03 ml squeeze flush device, 60" macro admin set and pressure tubing (152cm).A disconnection from the priming system connector was identified and there was a significant leak of saline on the patient's bed.The tubing level was fixed with a tracheal collar on the patient¿s arm.The device/tubing and the pressure bag of 0.9% nacl were changed/re-set up.Upon removal, a break was reported in the tubing of the device.The patient was reportedly calm and cooperative during the event.No hazardous substances were involved.There was no need for a medical intervention and no one was harmed during the event.However, the customer reported an infectious risk with a non-compliant closed system due to the leak.

Manufacturer Narrative

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

Manufacturer Narrative

The reported complaint of separation was confirmed on the returned set.During visual inspection of the device, the 60" pvc tubing was separated from the winged male luer.The tubing and the luer tubing pockets were microscopically examined; it appeared that there was sufficient solvent.The tubing was coiled when the male luer was not fully cured.The probable cause of the tubing separation was due to coiling the tubing before the solvent was fully cured during the manual assembly manufacturing process.A device history record review could not be conducted because the lot number is unknown.Date returned to mfg: 05oct2023.

• Brand Name: TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI
• 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: 17798864
• MDR Text Key: 324039523
• Report Number: 9617594-2023-00738
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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: 011-46106-74
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 0.9% NACL (NORMAL SALINE) PRESSURE BAG, MFR UNK; TRACHEAL COLLAR, MFR UNK