MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 22 GA X 1 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383512
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that at least three bd nexiva 22 ga x 1.75 in single port leaking just before it connects to the tubing.The following information was provided by the initial reporter: we have noticed several of our 22-gauge bd nexiva iv catheters leaking just before it connects to the tubing.It is leaking from the iv catheter, even before we connect it to anything.It happens with multiple nurses, so i can¿t say it¿s a nurse not doing something correctly.If we are only infusing saline, we can just put a towel underneath the area and infuse, but there is no way we would infuse chemo through a leaking catheter, so we have to restick the patient.We notice the leak as soon as it we place it and flush it.When i followed with customer they think they have seen this happen 4-5 time in last 3-4 weeks.
Additional Manufacturer Narrative
Investigation results: a device history record review was completed by our quality engineer team for provided material number 383512 and lot number 3180980.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Dhr was performed per the batch number supplied, but the material number associated with the batch cannot be confirmed since no response was received during follow up.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Material number updated to 383512.

• Brand Name: NEXIVA 22 GA X 1 IN SINGLE PORT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales UT ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18618309
• Report Number: 1710034-2024-00053
• Device Sequence Number: 12639674
• Product Code: FOZ
• UDI-Device Identifier: 30382903835134
• UDI-Public: (01)30382903835134
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: Other
• Device Catalogue Number: 383512
• Device Lot Number: 3180980
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown