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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER
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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER Back to Search Results
Model Number 382533
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter had some debris on it.Customer was inspecting tip of catheter prior to insertion and noticed some debris on the tip of the catheter.The rn did not inserted the catheter but saved it.
 
Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the samples submitted for evaluation.Bd received three units.Upon visual inspection, it was noted that one of the needle tips had a slightly thicker layer of lubricant; however, lubricant is not considered a foreign material as it is a part of the design.No foreign material was noted on any parts of the returned units.Bd was unable to confirm the reported defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.
 
Event Description
It was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter had some debris on it.Customer was inspecting tip of catheter prior to insertion and noticed some debris on the tip of the catheter.The rn did not inserted the catheter but saved it.
 
Event Description
It was reported that bd insyte autog bc pnk 20ga x 1.0in had foreign matter.The following information was provided by the initial reporter: the catheter had some debris on it.Verbatim: customer was inspecting tip of catheter prior to insertion and noticed some debris on the tip of the catheter.The rn did not inserted the catheter but saved it.
 
Manufacturer Narrative
The following fields have been updated with additional information: d.4.Medical device lot #: 1144503 h.4.Device manufacture date: 2021-05-24.
 
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Brand Name
BD INSYTE AUTOG BC PNK 20GA X 1.0IN
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12738217
MDR Text Key279626338
Report Number1710034-2021-00934
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00382903825332
UDI-Public00382903825332
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201075
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382533
Device Catalogue Number382533
Device Lot Number1144503
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2021
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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