MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE® CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	011-C1000
Medical Device Problem Codes	Backflow (1064); Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used 011-c1000 clave connector was returned for evaluation.A puncture was noted through the side wall below the top surface typical of a fold over stick down.The spike of the device had minor damage typical of fold over stick down puncture.There was no damage or anomalies noted to the body of the clave.A device history review (dhr) for lot 3678917 and relevant commodities were reviewed and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event involved a customer allegation stating that during connection to arterial access procedure, the microclave valves did not close after aspiration, noting blood leakage.There was patient involvement, no adverse event, no medical or surgical intervention provided, no clinically significant blood loss and no delay in critical therapy.

• Brand Name: CLAVE® CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 7987236
• Report Number: 9617594-2018-00061
• Device Sequence Number: 221856
• Product Code: FPA
• UDI-Device Identifier: 00840619000011
• UDI-Public: 00840619000011
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2018

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: 05/01/2023
• Device Model Number: 011-C1000
• Device Catalogue Number: 011-C1000
• Device Lot Number: 3678917
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1