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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD DISCARDITII SYRINGE; INTRAVASCULAR CATHETER
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BD MEDICAL, MEDICATION DELIVERY SOLUTIONS BD DISCARDITII SYRINGE; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 300844
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
 
Event Description
It was reported that bd discardit ii syringe had foreign matter the following information was received by the initial reporter with the following when removed from the packing nurse found hair inside the syringe.
 
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Brand Name
BD DISCARDITII SYRINGE
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key19119014
MDR Text Key341033928
Report Number9616066-2024-00579
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300844
Device Lot Number3334939
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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