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

Catalog Number	383557
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
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 sp with maxzero difficult to disengage needle.The following information was provided by the initial reporter: there have been 3 instances where the catheter will not separate from the needle.All 20g, all in the er, and all lot#4193548.One catheter has been sequestered at this time and they are going to keep me updated if there are any more issues.(b)(6).1.What is the date of event? 11/1/2024.2.Describe any patient harm, injury, complication or negative outcome that occurred because of the event: patient required additional stick for iv placement.(b)(6).I have an update on this question after seeing the impacted product: 2.Describe any patient harm, injury, complication or negative outcome that occurred because of the event: no harm.Unable to separate the catheter from the needle.Never used on the patient.
Additional Manufacturer Narrative
Investigation results: the complaint that the catheter would not separate from the needle was confirmed and the cause appeared to be manufacturing related.One 20ga nexiva unit from lot: 4193548 was provided for investigation.Resistance was noted when attempting to withdraw the needle through the tip shield.Debris was observed in the washer, which likely caused resistance when attempting to retract the needle.The damage was likely caused during manufacturing.The appropriate manufacturing personnel were notified of this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
No additional information.

• Brand Name: BD NEXIVA SP WITH MAXZERO
• 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: 20761051
• Report Number: 1710034-2024-01386
• Device Sequence Number: 15551899
• Product Code: FOZ
• UDI-Device Identifier: 00382903835577
• UDI-Public: (01)00382903835577(11)240711(17)270630(10)4193548
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2024

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: 383557
• Device Lot Number: 4193548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown