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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE AUTOGUARD BC; PERIPHERAL IV CATHETERS

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BECTON DICKINSON BD INSYTE AUTOGUARD BC; PERIPHERAL IV CATHETERS Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2024
Event Type  malfunction  
Event Description
Material: unknown, batch#: unknown.It was reported that the bd insyte autoguard bc leaked.The following information was provided by the initial reporter: "inserted non-blood control product but wasn't aware it wouldn't prevent leakage.When he turned to get something else it resulted in leakage." verbatim: rcc received a complaint via email.Email(s) attached.Clinician (radiologic technician) inserted non-blood control product but wasn't aware it wouldn't prevent leakage.When he turned to get something else it resulted in leakage.Clinician was used to blood control (iag bc) product and said that the two devices look really similar and at first he didn't know the difference.Comment observed during a voice of customer research study.Comment was general in nature.Clinician did not give any details about when the event occurred but mentioned it happened the first time he used the non-blood control device.
 
Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.D.3.Franklin lakes has been listed as the manufacturer.Device evaluation: as no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be confirmed.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD INSYTE AUTOGUARD BC
Type of Device
PERIPHERAL IV CATHETERS
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key19215274
MDR Text Key341576506
Report Number2243072-2024-00581
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/04/2024
Initial Date FDA Received04/30/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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