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

Catalog Number	383550
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
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 catheter had a hole.The following information was provided by the initial reporter: after inserting the catheter of the intravenous (iv) into the vein of a 36-day-old patient, there was visible flashback.The grey safety lock was retracted, and it was noted that there was a hole in the side of the cannula at the insertion site.Blood was found to be leaking from the hole.The iv system was removed, and another iv attempt was required.Patient injury: no.
Additional Manufacturer Narrative
Investigation results: the complaint of a leak was confirmed; however, the root cause could not be determined.One 24ga nexiva unit was received in an open unit package from lot #2249346.A functional test revealed a leak in the tubing and a microscopic examination of the leak site revealed a v-shaped breach in the tubing, which was consistent with needle puncture damage.The needle had been removed from the catheter and was not provided for investigation.As the device has been opened and separated from the needle, it is likely that the damage occurred during use; however, it could not be determined with certainty whether the damage originated during manufacturing or use of the device.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.Information will be captured on trend reports and monitored.

• 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: 19352249
• Report Number: 1710034-2024-00455
• Device Sequence Number: 7110165
• Product Code: FOZ
• UDI-Device Identifier: 00382903835508
• UDI-Public: (01)00382903835508
• 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
• Report Date (Section B): 06/06/2024

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: 06/30/2025
• Device Catalogue Number: 383550
• Device Lot Number: 2249346
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown