MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number	383531
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd nexiva needless connector fell off.The following information was provided by the initial reporter, translated from portuguese to english: when salinizing the avp of the nexiva 24, the second connector comes off due to the flow and needs to be replaced with a new connector.Materials unavailable.Additional information received on 27 sep 2024: is there any other impact to patient, if yes describe in detail.There was no impact on the patient.Was there any physical damage / defect found in the product? we do not have this information.Was another device required/used to complete the procedure? yes.How was the procedure completed? the connector had to be replaced.Could you please share any photo sample related to this event? unfortunately we don't have a photo or a sample, as it was necessary to dispose of it due to contamination.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383531 and lot number 3268504.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20507095
• Report Number: 1710034-2024-01184
• Device Sequence Number: 8401043
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317(11)230925(17)260930(10)3268504
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: Other
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 383531
• Device Lot Number: 3268504
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown