MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLIN; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426500406
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 19-transpac¿ trifurcated monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84", 3 3 ml squeeze flushes, 3 disposable transducers, macrodrip (pole mount) where it was reported that the green stop is cutting the tubing.It was further stated that it happened with the triple and single safe sets on the arterial lines snapping in half.There is unknown patient involvement, there was unknown patient harm, and unknown delay in therapy.
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.Plots: (b)(4) manufacturing date: 6/1/2023; expiration date: 6/1/2026.(b)(4) manufacturing date: 2/1/2023; expiration date: 2/1/2026.
Additional Manufacturer Narrative
The reported complaint of arterial lines snapped in half was confirmed.An image was provided by the customer showing the partial product.During visual inspection, the male luer was received broken from the rest of the set.The broken region had beach marks on it.It is typical of a bend break.The probable cause of the break had occurred due to unintentional bending forces applied during use.The possible lot numbers and relevant commodities were reviewed, no nonconformities were identified that may have contributed to the reported complaint.D4: only di provided as lot number is unknown.

• Brand Name: TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLIN
• 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: 19043488
• Report Number: 9617594-2024-00370
• Device Sequence Number: 15571172
• Product Code: DRS
• UDI-Device Identifier: 00840619045029
• UDI-Public: 00840619045029
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 06/01/2026
• Device Catalogue Number: 426500406
• Device Lot Number: PLOTS
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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
• Patient Sex: Unknown