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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 Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2022
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 foreign matter was found on the bd insyte¿ autoguard¿ bc shielded iv catheter before use.The following information was provided by the initial reporter: "he states that he has a soiled catheter found in a 20ml dotarem manual kit, batch number 22gk536a.He specifies that the product has not been used".
 
Manufacturer Narrative
H.6.Investigation summary: our quality engineer inspected the photograph for evaluation.Bd received one photograph which displayed a retracted needle assembly and a label for a 22g x 1.00in.Insyte autoguard bc pro product from lot number 1236833.Upon inspection of the photograph, foreign material was observed on the both the grip and barrel in the form of black specks of foreign material (fm) on them.Based on the appearance of the fm, it is likely that the fm is embedded.The reported issue was confirmed.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the molding process.The material was determined to be burnt particulate resin (non-foreign).The black specks were most likely created as part of the molding process.Burnt imbedded resin specks result from material build up in the barrel/screw.A device history record review showed no non-conformances associated with this issue during the production of this batch.The appropriate personnel have been notified.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that foreign matter was found on the bd insyte¿ autoguard¿ bc shielded iv catheter before use.The following information was provided by the initial reporter: "he states that he has a soiled catheter found in a 20ml dotarem manual kit, batch number 22gk536a.He specifies that the product has not been used".
 
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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 Key15660205
MDR Text Key306809594
Report Number1710034-2022-00616
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903810239
UDI-Public(01)00382903810239
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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