MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN BD NEXIVA NEARPORT; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 01/24/2024

Event Type  Injury  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that unknown bd nexiva nearport leaked.Material #: unknown batch#: unknown.It was reported by customer that after multiple attempts with pivo vat called to eval leaking piv.Via ultrasound vein found to be extremely phlebitis.Pt complaining of pain with flushing.Piv dc'ed and new piv started.Verbatim: complaint received via email(s) attached.After multiple attempts with pivo vat called to eval leaking piv.Via ultrasound vein found to be extremely phlebitis.Pt complaining of pain with flushing.Piv dc'ed and new piv started.

Manufacturer Narrative

No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.We would be very interested in examining product that does not meet your expectations and our quality standards.A photo of the defect could assist our quality team in their investigation.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information received.

• Brand Name: UNKNOWN BD NEXIVA NEARPORT
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18705129
• MDR Text Key: 335406424
• Report Number: 9610847-2024-00029
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention