MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426480406
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been discarded.It is not available for investigation.
Event or Problem Description
The event involved a transpac where upon set up the connection fell apart at the blood sampling port.There was no report of human harm, nor adverse event, nor medical intervention.
Additional Manufacturer Narrative
The reported complaint of a sample port falling off is confirmed from the provided picture; however, the probable cause of the separation cannot be determent without the product available for a full evaluation to determine the cause of the separation.The lot # 3826775 and relevant commodities were reviewed and there were no non-conformances found.

• Brand Name: TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT
• 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.
• MDR Report Key: 8286763
• Report Number: 9617594-2019-00022
• Device Sequence Number: 13967230
• Product Code: DRS
• UDI-Device Identifier: 00840619045012
• UDI-Public: (01)00840619045012(17)211001(10)3826775
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 10/01/2021
• Device Catalogue Number: 426480406
• Device Lot Number: 3826775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR