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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD CHECK VALVE,MALE/FEMALE LUER LOCK INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON BD CHECK VALVE,MALE/FEMALE LUER LOCK INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 4302243317
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. The manufacturing location for this product is (b)(4). This site is not registered with the fda. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
Event Description
It was reported that bd check valve, male/female luer lock had blood backflow during infusion. The following information was provided by the initial reporter: "the valve does not work, blood flows through".
 
Event Description
It was reported that bd check valve, male/female luer lock had blood backflow during infusion. The following information was provided by the initial reporter: "the valve does not work, blood flows through".
 
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. The manufacturing location for this product is (b)(4). This site is not registered with the fda. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
 
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Brand NameBD CHECK VALVE,MALE/FEMALE LUER LOCK
Type of DeviceINTRAVASCULAR 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 Key12872647
MDR Text Key286266726
Report Number2243072-2021-02830
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
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 12/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4302243317
Device Lot Number1020447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2021
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

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