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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Illegible Information (4050)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2022
Event Type  malfunction  
Event Description
It was reported while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga the label was streaked and illegible.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that some packaging had black strips across label.Verbatim: during iagbc pro training with nursing personnel, (clinical specialist) noticed that the packaging of some samples had a black streak across it.
 
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 while using bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 22ga the label was streaked and illegible.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that some packaging had black strips across label.Verbatim: during iagbc pro training with nursing personnel, (clinical specialist) noticed that the packaging of some samples had a black streak across it.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 08-sep-2022.H.6.Investigation summary: bd received a sealed 22 gauge insyte autoguard blood control unit from lot 2118383 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed black tape on the unit's packaging.Therefore, based off the visual inspection the engineer was able to verify the reported defect.It was determined that this was a manufacturing defect that occurred during the packaging process.The black tape was found to be splice tape that held two rolls of packaging tape together during packaging.The manufacturing facility has been notified of this incident and the findings.A notification was issued to the packaging department to raise awareness of this issue and ensure that proper steps are being taken to prevent recurrence.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY 22GA
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 Key15352310
MDR Text Key305702701
Report Number1710034-2022-00473
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number381023
Device Lot Number2118383
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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