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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 22GA 1.00IN Y; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA 22GA 1.00IN Y; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383532
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/05/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that nexiva 22ga 1.00in y had no label.This occurred on 6 occasions.The following information was provided by the initial reporter: nexiva product which has no labeling on the packet.There were 6 single cannulas out of the box of 20 which had no labeling on the outside packet on each cannula.
 
Event Description
It was reported that nexiva 22ga 1.00in y had no label.This occurred on 6 occasions.The following information was provided by the initial reporter: nexiva product which has no labeling on the packet.There were 6 single cannulas out of the box of 20 which had no labeling on the outside packet on each cannula.
 
Manufacturer Narrative
H6: investigation summary.Our quality engineer inspected the photographs submitted for evaluation.Bd received a photograph which displayed missing label content.The reported issue was confirmed.Our engineer has determined that the most likely root cause for this event is related to the splicing of one roll of packaging backing to the next.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
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Brand Name
NEXIVA 22GA 1.00IN Y
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key11936104
MDR Text Key262895780
Report Number1710034-2021-00470
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903835324
UDI-Public00382903835324
Combination Product (y/n)N
PMA/PMN Number
K183399
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2023
Device Catalogue Number383532
Device Lot Number0181196
Was Device Available for Evaluation? No
Date Manufacturer Received06/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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