MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Model Number 383531

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

It was reported that the bd nexiva¿ closed iv catheter system is able to fall out.The following information was provided by the initial reporter: the black portion of the label is not sealed.Product is able to fall out.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Our quality engineer inspected the photograph submitted for evaluation.Bd received one photo which displayed four 24g nexiva devices in the individual unit packaging.Two devices showed what appeared to be black splice tape on the top web packaging.The product, lot, and expiration information was not printed on the label with the splice tape that was shown with the top web up.It could not be visually confirmed if the packaging was open along the black material, but it is likely that the material prevented a complete seal of the packaging.The reported issue was confirmed.The black tape is from the manufacturing process and used during the splice process.The black tape is used when a new roll of webbing is being installed.Splicing helps align and put the new webbing into the machine.Tape is put on the roll to signal the system to not fill the pockets at the spliced location.It is the operator¿s job to follow the splice through the machine to insure it travels through the machine as desired.Also, to make sure the row with the splice is discarded by the vision system at the end of the machine.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h10.

Event Description

It was reported that the bd nexiva¿ closed iv catheter system is able to fall out.The following information was provided by the initial reporter: the black portion of the label is not sealed.Product is able to fall out.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15714992
• MDR Text Key: 306812898
• Report Number: 1710034-2022-00643
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 383531
• Device Catalogue Number: 383531
• Device Lot Number: 2102869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1