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

Catalog Number	383531
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/30/2024
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.B3.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that bd nexiva, unable to remove needle.The following information was provided by the initial reporter: upon the cannula going into the patient, the nurse was unable to remove the introducer (metal needle).
Additional Manufacturer Narrative
Current control there is functional inspection for activation test for every batch.As there is no abnormality during the production run and no photo/samples were returned for investigation.No root cause could be established for this reported.Complaint received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
Upon the cannula going into the patient, the nurse was unable to remove the introducer (metal needle).Confirmation of a product fault/failing.

• 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 MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19586237
• Report Number: 1710034-2024-00633
• Device Sequence Number: 12582613
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317(10)3114096
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 383531
• Device Lot Number: 3114096
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 10/08/2024
• 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