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, 24" TU; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426480406
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one unused transpac® iv monitoring kit w/ safeset reservoir and blood sampling port, 24" tubing, disposable transducer, 03 ml squeeze flush, macrodrip (patient mount) for testing and evaluation.The reported complaint of a tubing separation was confirmed.The received monitoring kit sample had a bond separation between the safeset port and the 3" tubing.The cause of the separation was due to a manual manufacturing process error of administering insufficient solvent at the bond location.Manufacturing batch review: the lot # 3826775 and relevant commodities were reviewed and there were no non-conformance found.
Event or Problem Description
The event involved a transpac that upon set up the connection fell apart at the blood sampling port.There was no report of patient involvement, nor adverse event, nor medical intervention.
Event or Problem Description
User facility medwatch received with additional information stating that the original intended procedure was arterial line monitoring and the patient was in the pediatric intensive care unit (picu).
Additional Manufacturer Narrative
Medsun/medwatch received.

• Brand Name: TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR AND BLOOD SAMPLING PORT, 24" TU
• 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: 8278279
• Report Number: 9617594-2019-00017
• Device Sequence Number: 13847549
• 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): 01/02/2019

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?: Yes
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 138