MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426320405
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for investigation.It has not been received.
Event or Problem Description
The event occurred at 9:00 am and involved a transpac® iv monitoring kit, 72" (183 cm), disposable transducer, 03 ml squeeze flush device, macrodrip (pole mount) that the customer reported blood backing up into the transducer tubing.The line was traced back and it was noted to have disconnected above one of the luer lock connectors of the transducer line.Additionally, it was mentioned the tubing came disconnected from the luer plastic.The device was clamped to control the blood flow and the transducer was replaced.There was no patient harm as a result of the event.
Additional Manufacturer Narrative
Received one used list# 426320405, transpac® iv monitoring kit, 72", disposable transducer, 3 ml squeeze flush, macrodrip (pole mount) lot# 4986114 and used bd syringe 10 ml on (b)(6) 2021 for evaluation.The reported complaint of blood backing up into the transducer tubing was confirmed on the returned set.During visual inspection, the 48.5" pressure tubing was found separated from the female luer.The pressure tubing was found tacky at the bond site.The separation of the bond was due to the pressure tubing being tacky.The probable cause of the pressure tubing being tacky is due to the solvent on the tubing not being fully cured during assembly process.A lot review was performed and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: TRANSPAC IV MONITORING KIT, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC
• 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
• MDR Report Key: 11697907
• Report Number: 9617594-2021-00131
• Device Sequence Number: 3437961
• Product Code: DRS
• UDI-Device Identifier: 00840619033811
• UDI-Public: (01)00840619033811(17)230901(10)4986114
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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 Expiration Date: 09/01/2023
• Device Catalogue Number: 426320405
• Device Lot Number: 4986114
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1