MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383517

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

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 Description

It was reported that bd nexiva safety shield broke.The following information was provided by the initial reporter: safety shield on the needle broke upon removal from the iv catheter/patient¿s arm, no harm to the patient.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: received one unit of a 20gx1.25in nexiva device from an unknown lot number for the investigation of this complaint.A gross visual inspection shows that only few components of the unit were returned; a v-clip that has been separated from the unit and a needle protruding from the grip and held by the washer, which was positioned within the tip shield.The catheter assembly was decoupled and not returned.The safety shield was not engaged, and the needle was exposed.Per the customer¿s investigation, the safety shield of the needle broke upon removing the unit from the patient¿s arm.There were no other physical damages on the unit.Investigation was conducted by inspecting both the tip shield and the v-clip under the microscope.No physical damage was observed on either of the returned components.During manufacturing the v-clip may be mounted incorrectly due to machine misalignment.As the v-clip is seated into the tip shield any misalignment may cause the groove to not catch correctly.Therefore, during decoupling of the unit, the v-clip may fall as the only thing holding it is the engaged needle.Investigation conclusion(s): the defect of ¿shield defective¿ was confirmed.Probable root cause(s): manufacturing.A notification of awareness has been sent to the manufacturing department.

• Brand Name: BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT
• Type of Device: INTRAVASCULAR CATHETER
• 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: 18583525
• MDR Text Key: 333927475
• Report Number: 1710034-2024-00036
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: (01)30382903835172
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• 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: 02/27/2024

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
• Device Operator: Other
• Device Catalogue Number: 383517
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 02/27/2024
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1