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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CONNECTA; INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON UNSPECIFIED BD CONNECTA; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem Unspecified Infection (1930)
Event Date 01/25/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that unspecified bd" connecta leaked and the stopcock disconnected.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported via post market survey that the clinician encountered occurrences of infection (9), the bd plug is disconnected from the bd connecta" stopcock(s) in packaging (2), the bd plug is loose on bd connecta" stopcock(s) (42), the bd plug inadvertently disconnects from bd connecta" stopcock port during use (20), and the plug does not screw in (45).
 
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Brand Name
UNSPECIFIED BD CONNECTA
Type of Device
INTRAVASCULAR ADMINISTRATION SET
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11358623
MDR Text Key232852454
Report Number2243072-2021-00500
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2021
Initial Date FDA Received02/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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