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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; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381023
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
Event Type  malfunction  
Event Description
It was reported that black foreign matter was found on the bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter, translated from japanese: "during the inspection at the customer's side, black dirt on the product was found.".
 
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
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 30-jun-2022.Investigation summary: bd received 49 unsealed 22 gauge insyte autoguard blood control pro units from lot 1236833 for evaluation.Additionally, 9 photos were provided for investigation.Our quality engineer visually inspected the returned units and observed brown dirt and black spots that appeared to be ink on several of the units.Therefore, based off the visual inspection the engineer was able to verify the reported defect.The dhr for lot 1236833 has been reviewed.This lot was built and packaged on afa line 12 from 26-aug-2021 through 29-aug-2021 for a quantity of (b)(4).No related quality issues or process deviations were found.
 
Event Description
It was reported that black foreign matter was found on the bd insyte¿ autoguard¿ bc shielded iv catheter.The following information was provided by the initial reporter, translated from japanese: "during the inspection at the customer's side, black dirt on the product was found.".
 
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Brand Name
BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
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 Key14844484
MDR Text Key303093311
Report Number1710034-2022-00326
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K201075
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 08/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381023
Device Lot Number1236833
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2021
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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