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

Catalog Number	383531
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva needle pierced the catheter the following information was provided by the initial reporter: nexiva 24 gauge -as rn was trying to access patient¿s vein the needle came away from the plastic catheter.
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
Customer response on (b)(6) 2024 there was no serious life-threatening injury that occurred due to this event.
Additional Manufacturer Narrative
Additional information received.E/f code update.
Additional Manufacturer Narrative
Investigation results: our quality engineer inspected the photograph and sample submitted for evaluation.Bd received one photo and 24gx0.75in nexiva device from lot number 3320146.The unit on the photo appears to be the physical return unit.The needle was received protruding through the catheter tubing.What appeared to be blood residue was observed throughout the catheter tubing, which indicates that the product was used.Your reported issue was confirmed.As the unit is observed to have been used, it is unlikely that the damage occurred during manufacturing.Had the defect occurred during manufacturing, the condition of the catheter and needle would render the device unusable.It is likely that the needle and catheter were inserted far enough to access the vessel, after which the needle was retracted and reinserted to puncture the catheter.Please refer to the ifu (instructions for use) which indicate that if the needle is partially or completely withdrawn from the catheter tubing during insertion, do not re-insert the needle into the catheter tubing as damage may occur.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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: 19392723
• Report Number: 1710034-2024-00489
• Device Sequence Number: 7799470
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2024

1 Device 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: 3320146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: Not provided; 07/31/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/03/2024; 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial