MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR CATHETER

Catalog Number	383558
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that while opening up a 1.75in bd nexiva¿ single-port with maxzero¿ needle-free connector, a 1.25in was inside the packaging instead.The following information was provided by the initial reporter: "good afternoon.Today it was reported to me that a customer went to open a 20g 1.75in nexiva and inside the packaging was a 1.25in nexiva.The packaged product ref # is (b)(4).The sample is available and was not used.Can you please send shipping material to me so that i may send it in to be examined?".
Additional Manufacturer Narrative
H.6.Investigation: since a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode.
Event or Problem Description
It was reported that while opening up a 1.75in bd nexiva¿ single-port with maxzero¿ needle-free connector, a 1.25in was inside the packaging instead.The following information was provided by the initial reporter: "good afternoon.Today it was reported to me that a customer went to open a 20g 1.75in nexiva and inside the packaging was a 1.25in nexiva.The packaged product ref # is 383558.The sample is available and was not used.Can you please send shipping material to me so that i may send it in to be examined?".

• Brand Name: BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8456016
• Report Number: 9610847-2019-00249
• Device Sequence Number: 2746406
• Product Code: FOZ
• UDI-Device Identifier: 30382903835585
• UDI-Public: 30382903835585
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K170336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 383558
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other