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

Catalog Number 383517

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the bd nexiva¿ closed iv catheter system had ¿a part of the catheter and a part of the needle cover were out of package and sealed.The out parts were cut.¿ found before use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received one sample unit for evaluation.It was observed that part of the product popped out of the packaging prior to the sealing process.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to this observed defect.Level a mdr investigation: dhr review - all challenges and inspections were conducted successfully and no related issues were identified.Qn review - no quality notifications were initiated relating to the defect.Eura review - the cause of the defect was a part out of pocket and the occurrence of this defect does not exceed what is considered acceptable.Visual analysis - the returned sample was inspected and found that the part was in the seal area of the package.The defect was confirmed during the investigation.The part popped out of the pocket prior to the sealing process.Investigation conclusion: the part popped out of the pocket prior to the sealing process.There are two inspection systems to detect part(s) out of pocket prior to sealant of the packages, a physical gate and a visual inspections.However, these inspections are not immediately before the sealing process, which allows a part that pops out of the pocket after the inspections to go undetected.After the sealing process, the packages are then cut and boxed automatically.Manufacturing personnel have been notified of this incident and the findings.The defect rendered the part unusable.The severity and occurrence of this incident does not exceed what is considered acceptable in the eura.

• 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
• MDR Report Key: 7278430
• MDR Text Key: 100528770
• Report Number: 1710034-2018-00044
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835172
• UDI-Public: 30382903835172
• Combination Product (y/n): N
• PMA/PMN Number: K161777
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

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: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 383517
• Device Lot Number: 7214627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other