MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42800-39
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.However; testing has not yet been completed.
Event or Problem Description
The event involved a transpac it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve where the reported stated that the extension that connects the transducer set to the infusion set became disconnected during patient use.The device was used with normal saline.The set up was transducer to alaris tubing.There was a patient involvement and delay in therapy, but no adverse event.
Additional Manufacturer Narrative
Received one used.List #42800-39, transpac¿ it monitoring kit, 27", 30 ml flush device, 10 cc contamination syringe and needleless valve; lot #8602165.The reported complaint of a tubing separation was confirmed on the returned set.During visual inspection, the pvc tubing was found separated from the transducer luer pocket.The tubing was microscopically examined and insufficient adhesive coverage was observed on the pvc tubing.The probable cause of the separation had occurred due to insufficient adhesive coverage applied during assembly at manufacturing.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 27", 30 ML FLUSH DEVICE, 10 CC CONTAMINATION SYRING
• 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: 15974283
• Report Number: 9617594-2022-00322
• Device Sequence Number: 15177019
• Product Code: DRS
• UDI-Device Identifier: 00887709098169
• UDI-Public: (01)00887709098169(17)250901(10)8602165
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/16/2022

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: 09/01/2025
• Device Model Number: 42800-39
• Device Catalogue Number: 42800-39
• Device Lot Number: 8602165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TUBING, BD ALARIS MFR
• Patient Sex: Unknown