MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 60", 3ML FLUSH DEVICES, MACRODRIP (POLE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42800-07
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date and involved a transpac¿ it trifurcated monitoring kit, 60", 3ml flush devices, macrodrip (pole mount).The customer reported that the device came back repacked as defective as it disconnected while in use during a case.There was no report of human harm and no other information is available regarding this reported issue at this time.
Additional Manufacturer Narrative
The following items wer received for investigation: one case (23 of 75) of 10 new list #42800-07, transpac¿ it trifurcated monitoring kit, 60", 3ml flush devices, macrodrip (pole mount); lot #5819705.One case (16 of 75) of 10 new list #42800-07, transpac¿ it trifurcated monitoring kit, 60", 3ml flush devices, macrodrip (pole mount); lot #5819705.Visual: 20 new list #42800-07, trifurcated monitoring kits were received.A similar complaint with the same lot number was confirmed for separation due to the tubing being tacky.No visual anomalies were observed on the returned sets.Functional: when the returned sets were primed and pressure leak tested, no leaks were observed.A pull test was conducted between the pvc tubing and the tubing pocket of the transducer.All the sets pulled within the specification limits.For 19 out of 20 sets, the pvc tubing pulled off from the luer over 6 lbs which is within the specifications limit of 6 lbs.For the remaining set, the pvc tubing broke near the luer over 6 lbs.19 out of 20 sets had tubing pockets that were observed to be tacky.The probable cause of the tubing pockets being tacky had occurred due to uv adhesive not being fully cured during the manufacturing assembly process.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 9/9/2022.

• Brand Name: TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 60", 3ML FLUSH DEVICES, MACRODRIP (POLE
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15380807
• Report Number: 9617594-2022-00262
• Device Sequence Number: 5506254
• Product Code: DRS
• UDI-Device Identifier: 00887709097629
• UDI-Public: (01)00887709097629(17)250201(10)5819705
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• 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): 08/24/2022

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: 02/01/2025
• Device Model Number: 42800-07
• Device Catalogue Number: 42800-07
• Device Lot Number: 5819705
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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