MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA CLOSED IV CATHETER SYST., DUAL PORT, MAXZERO NEEDLE-FREE CONNECTOR; INTRAVASCULAR CATHETER

Catalog Number	383571
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
It was reported when using the bd nexiva¿ closed iv catheter syst., dual port, maxzero¿ needle-free connector, the device experienced safety mechanism, needle disengagement (removal) difficulty.This event occurred three times.The following information was provided by the initial reporter.The customer stated: "stiff cannula, difficult to remove despite loosening." follow up "i've had a few problems with really stiff cannulas as i've tried withdrawing the needle and as a result, i've 'blown' a few vein's annoyingly, vein's i previously wouldn't have done this to.This is despite loosening the device before use.".

• Brand Name: BD NEXIVA CLOSED IV CATHETER SYST., DUAL PORT, 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 ; MX
• MDR Report Key: 11825595
• Report Number: 9610847-2021-00213
• Device Sequence Number: 17201037
• Product Code: FOZ
• UDI-Device Identifier: 00382903835713
• UDI-Public: 00382903835713
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: Other
• Device Catalogue Number: 383571
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1