MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S.A. DE C.V. 24" SAFESET RESERVOIR W/NEEDLELESS VALVE; CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing and investigation confirmed the arterial tubing was separated from the female luer and the probable cause was determined to be the uv adhesive which was not fully cured; thus, the defect was due to a manual manufacturing process error.
Event or Problem Description
The customer contact reported the safeset broke apart during a case; thus, there was patient involvement, but no reported harm or medical intervention.No additional information has been provided.

• Brand Name: 24" SAFESET RESERVOIR W/NEEDLELESS VALVE
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S.A. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8134326
• Report Number: 9617594-2018-00214
• Device Sequence Number: 1233979
• Product Code: KRA
• UDI-Device Identifier: 00887709042537
• UDI-Public: (01)00887709042537(17)210801(10)3778262
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K932188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2018

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 Expiration Date: 08/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 42328-66
• Device Lot Number: 3778262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1