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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 Break (1069)
Patient Problem Laceration(s) (1946)
Event Date 02/12/2018
Event Type  malfunction  
Manufacturer Narrative
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.The initial reporter also notified the fda in march 2018, via medwatch # (b)(4).Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that while using a unspecified bd¿ syringe, the syringe broke in the user¿s hand and lacerated their finger.There was no report of medical intervention.
 
Manufacturer Narrative
Additional information: bd received a sample from customer.The sample received from the customer was a non-bd product.It has been determined that this complaint has been over reported, as this is not a reportable bd complaint.
 
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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 Key7412719
MDR Text Key105374706
Report Number2243072-2018-00177
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2018
Date Manufacturer Received03/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age30 YR
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