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

Catalog Number	393529
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Address information was not provided, therefore, xx was used as a place holder.Investigation the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history (chr) review could not be performed as no batch/lot number was made available for this reported event.A device history record(dhr) review could not be performed as no batch/lot number was made available for this reported event.Complaints received for this device and reported condition will continue to be tracked and trended.
Event or Problem Description
It was reported that bd nexiva w/ maxzero tubing ballooned.The following information was provided by the initial reporter: during power injection of ct contrast with nexiva nearport pivc, tubing ballooned between nearport and iv hub.No patient/hcp harm.

• Brand Name: BD NEXIVA W/ 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: 19934971
• Report Number: 1710034-2024-00847
• Device Sequence Number: 7433474
• Product Code: FOZ
• UDI-Device Identifier: 00382903935291
• UDI-Public: (01)00382903935291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2024

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: 393529
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown