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

Catalog Number	383576
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 20ga x 1.00 in dp with maxzero needle disengagement is difficult.The following information was provided by the initial reporter: customer stated that after catheter is advanced the needle hub got stuck and wouldn't come off easily.Took multiple people attempting to get it twisted off.What is the number of occurrences? nursing staff report multiple occurrences.Is there any adverse event or serious injury occurred? no.Are you able to send sample to bd for investigation? if yes, please provide mailing address.I gave the sample to our medline rep who was going to send it in.Please provide event date.I don¿t remember.I think it was early october.Are you able to identify the batch number? no gave the iv catheter and kit to the medline rep.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.
Additional Manufacturer Narrative
Investigation results: a device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.
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: 18186428
• Report Number: 1710034-2023-01333
• Device Sequence Number: 15114889
• Product Code: FOZ
• UDI-Device Identifier: 00382903835768
• UDI-Public: (01)00382903835768
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 383576
• Device Lot Number: 3166702
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown