MAUDE Adverse Event Report: BD SUZHOU (MDS) BD NEXIVA DIFFUSICS W/MAXZERO 18G X 1.25 IN; INTRAVASCULAR CATHETER

Catalog Number	383588
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history record(chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record(dhr) review could not be performed as no batch/lot number was made available for this reported event.A review of the applicable aeura rm5769 rev27(aa) indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.
Event or Problem Description
It was reported that bd nexiva diffusics w/maxzero 18g x 1.25 in connection issues it was reported by customer that port attachment disconnected from catheter while flushing.Verbatim: rcc received a complaint via email.Email(s) attached.Port attachment disconnected from catheter while flushing.

• Brand Name: BD NEXIVA DIFFUSICS W/MAXZERO 18G X 1.25 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20632062
• Report Number: 9610847-2024-00340
• Device Sequence Number: 7929756
• Product Code: FOZ
• UDI-Device Identifier: 00382903835881
• UDI-Public: (01)00382903835881
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K233529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2024

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 Catalogue Number: 383588
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown