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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE
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BECTON DICKINSON UNSPECIFIED BD SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
It was reported that unspecified bd¿ syringe was cracked.The following information was provided by the initial reporter: it was reported by the health professional the syringe cracked apart and almost caused the needle to be directed.
 
Event Description
It was reported that unspecified bd¿ syringe was cracked.The following information was provided by the initial reporter: it was reported by the health professional the syringe cracked apart and almost caused the needle to be directed.
 
Manufacturer Narrative
Complaint is being cancelled.Not a bd product.Product was received at bd manufacturing site and it was determined that this is not bd product.
 
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Brand Name
UNSPECIFIED BD SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12316183
MDR Text Key267253051
Report Number2243072-2021-02064
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2021
Date Manufacturer Received08/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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