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

Catalog Number 383539

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

Event Type  malfunction  

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.

Event Description

It was reported by owes & minor that when activating the bd nexiva closed iv catheter system safety shield, the shield fell off leaving the needle exposed.No report of needle stick injury or medical intervention noted.

Manufacturer Narrative

Expiration date: 02/21/2028.Expiration date: 02/28/2021.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported by owes & minor that when activating the bd nexiva¿ closed iv catheter system safety shield, the shield fell off leaving the needle exposed.No report of needle stick injury or medical intervention noted.

Event Description

It was reported by owes & minor that when activating the bd nexiva¿ closed iv catheter system safety shield, the shield fell off leaving the needle exposed.No report of needle stick injury or medical intervention noted.

Manufacturer Narrative

H.6.Investigation summary: device/batch history record review: lot 8087800; was built on nfa line 1 from 29mar2018 through 04apr2018 for the quantity.Review disclosed no indication of the alleged failure as there were no related reject activity findings throughout the build of this lot that would impact upon the quality relevant to the defect of the product as stated in the pir.There were 2 non-related qns initiated during the build of this lot and no related qns.All required challenge samples and testing during the build of the catheters was performed per specifications, in accordance with the in-process sampling plans.Analysis of peura and/or fmea conducted by qe: to determine level of risk and potential causes of the defect: the analysis of peura (end user risk analysis) rm5796 rev.16 version (o) was analyzed to determine the risk to customer.The analysis disclosed that due to low occurrence and limited severity, current risk is acceptable.This incident does not exceed what is considered acceptable.The causes could not be investigated or confirmed without the sample.Visual analysis observations and testing: observations and testing could not be performed because units were not provided for investigation.Investigation conclusion: root cause.Relationship of device to the reported incident: indeterminate - the alleged defect described in the product incident report was not confirmed or replicated; as units were not provided for this incident, therefore a definite root cause could not be established.Comment: refer to corrections and cap below.

• 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: 7637749
• MDR Text Key: 112447213
• Report Number: 1710034-2018-00356
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835393
• UDI-Public: 00382903835393
• Combination Product (y/n): N
• PMA/PMN Number: K111366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 383539
• Device Lot Number: 8087800
• Date Manufacturer Received: 06/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other