MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 60", 03 ML SQUEEZE FLUSH DEVICE, 2 3 WAY STOPCOCKS; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46112-10
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that with regards to a transpac® iv monitoring kit, 60", 03 ml squeeze flush device, 2 3 way stopcocks and macrodrip that the spike broke at the set right at the bag.The registered nurse was releasing pressure on the iv fluid/pressure bag to change the iv fluid bag when she recognized that the spike had snapped off and was inside the iv fluid bag.There was patient involvement and no harm reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary when additional reportable information becomes available.
Event or Problem Description
Correction: additional information was provided by the customer on 15-may-2025 from the event occurred when the patient had this pressurized iv tubing in use for arterial line monitoring under 24 hours before the spike from the drip chamber broke in the iv fluid bag.  the rn was releasing pressure on the iv fluid/pressure bag to change the iv fluid bag when she recognized that the spike had snapped off and was inside the iv fluid bag.  since this was a pressurized line for arterial hemodynamic monitoring- the blood backed up into the tubing.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: one used partial list# 46112-10, transpac® iv monitoring kit, 60", 03 ml squeeze flush device, 2 3 way stopcocks and macrodrip; lot# unknown one used list# unknown, 0.96% sodium chloride injection 500ml iv bag; lot# unknown the reported complaint of breakage was confirmed.During visual inspection, the spike of the drip chamber was received broken.A part of the spike is still inside the iv bag.Plastic deformation and stress marks were observed at the broken region.The probable cause of broken spike had occurred due to unintentional bending and twisting forces applied during use.A dhr lot# review could not be conducted because no lot number was identified.D9 - date returned to mfg:18jun2025 corrected information can be found in b5, e3, g2 and h6 component code.

• Brand Name: TRANSPAC® IV MONITORING KIT, 60", 03 ML SQUEEZE FLUSH DEVICE, 2 3 WAY STOPCOCKS
• Common Device Name: 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: 22184143
• Report Number: 9617594-2025-01195
• Device Sequence Number: 15595884
• Product Code: DRS
• UDI-Device Identifier: 00887709061781
• UDI-Public: 00887709061781
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 46112-10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARTERIAL LINE MONITORING SYSTEM/MATERIALS, MFR UNK.; IV FLUID/PRESSURE BAG, MFR UNK.
• Patient Sex: Unknown