MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT

Model Number	42632-05
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned to the manufacturer for investigation.It has not yet been received.
Event or Problem Description
The event involved a customer report of a transpac iv monitoring kit that disconnected at the connection of the device.It was reported that there was suspicion of missing solvent to glue it properly.No adverse patient consequences reported.
Additional Manufacturer Narrative
One (1) used 'partial set', transpac iv mgt.Kit was received for evaluation with no tubing separation.The kit was primed and pressure tested.During priming, a leak was observed between the male luer and the 60" administration tubing.The administration tubing was found to separate during handling of the product, confirming a separation between the administration tubing and the male luer.This was caused by insufficient solvent around the tubing.

• Brand Name: TRANSPAC® IV MONITORING KIT
• Common Device Name: TRANSPAC® IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7161807
• Report Number: 9617594-2018-00002
• Device Sequence Number: 1407624
• Product Code: DRS
• UDI-Device Identifier: 00840619033811
• UDI-Public: 840619033811
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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 Model Number: 42632-05
• Device Catalogue Number: 42632-05
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/29/2018
• Patient Sequence Number: 1