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

Catalog Number	011-A1000
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return to the manufacturer for investigation; it has not been received.
Event or Problem Description
The date of the event is unknown.The event involved a nanoclave¿ connector that did not allow flow when the anesthetist attempted to inject emergency medications through the connector.The customer stated it was near impossible to inject, even with pressure.This report captures the first of two incidents.
Additional Manufacturer Narrative
H10: one (1) new list# 011-a1000, nanoclave¿ connector, lot# 3970567 was received for testing on (b)(6)2020.The single new in sterile package 011-a1000 nanoclave connector was flow tested at gravity pressure and the 011-a1000 nanoclave met fluid flow expectations outlined in the product performance specification.No mating devices were returned to evaluate with the 011-a1000 nanoclave connector.The complaint was unable to be confirmed or replicated.A dhr (device history review) lot# 3970567 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: NANOCLAVE CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 9688014
• Report Number: 9617594-2020-00043
• Device Sequence Number: 11676012
• Product Code: FPA
• UDI-Device Identifier: 00840619060909
• UDI-Public: (01)00840619060909(17)240201(10)3970567
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 02/01/2024
• Device Catalogue Number: 011-A1000
• Device Lot Number: 3970567
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1