MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 104" (264 CM) APPX 7.1 ML, TRANSFER SET W/MICROCLAVE®, DUAL CHECK VALVE, SMALLBO; ADMINISTRATION SETS AND ACCESSORIES

Model Number	B33065
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No b33065 product samples, videos, or photographs were returned for investigation.The dhr was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
Event or Problem Description
The event involved a customer report against an extension set stating that one of the microclaves disconnected from a carefusion tpn tubing.The disconnection occurred at the rotating luer end.The device was changed and no further issues occurred.The customer further stated that the patient did develop a bloodstream infection, but can't attribute the disconnection directly to the event.

• Brand Name: 104" (264 CM) APPX 7.1 ML, TRANSFER SET W/MICROCLAVE®, DUAL CHECK VALVE, SMALLBO
• Common Device Name: ADMINISTRATION SETS AND ACCESSORIES
• 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: 8840424
• Report Number: 9617594-2019-00246
• Device Sequence Number: 1400756
• Product Code: FMG
• UDI-Device Identifier: 00887709006102
• UDI-Public: (01)00887709006102(17)240401(10)4040260
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2019

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: 04/01/2024
• Device Model Number: B33065
• Device Catalogue Number: B33065
• Device Lot Number: 4040260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1