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

Model Number 383511

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that the packaging label was printed improperly on the bd nexiva¿ closed iv catheter system.This event occurred 2 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: "bad printing.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received two unopened units and two photographs.Visual inspection of the returned units found that the print was missing completely on one unit and the other had only the topmost line of print present.Additionally, single piece of torn black tape was also found adhered to the top web of both units.The reported issue was confirmed.The missing print most likely occurred as a result of human error during the manual inspection process.The black tape seen on the unit was likely introduced during the packaging process since the tape is flush with the edge of the units, suggesting that it was likely cut by the blades that cut out the packages.There is an automated vision system in place that inspects the products during manufacturing.It is the operator¿s responsibility to ensure that units with black tape and/or missing print are rejected.The presence of black tape and missing print indicates that the defect is related to operator/ manufacturing error.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.

Event Description

It was reported that the packaging label was printed improperly on the bd nexiva¿ closed iv catheter system.This event occurred 2 times.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: "bad printing.".

• 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: 13232949
• MDR Text Key: 285702245
• Report Number: 1710034-2021-01112
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: 30382903835110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 383511
• Device Catalogue Number: 383511
• Device Lot Number: 1155418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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