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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 Problems Disconnection (1171); Material Separation (1562); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/25/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.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).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that stopper separation occurred with a unspecified bd syringe.The following information was provided by the initial reporter, "it was reported that the stopper separated from the plunger rod on one syringe and in another syringe the stopper was twisted and would not allow the plunger to move.Event description per customer's email states, "i have two 10ml syringes with luer lok tip that has dislodged/disconnected black piece from the plunger.One lost all suction and ability to be used and one the black piece is twisted and will not allow plunger to move.".
 
Manufacturer Narrative
Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.
 
Event Description
It was reported that stopper separation occurred with a unspecified bd syringe.The following information was provided by the initial reporter, "it was reported that the stopper separated from the plunger rod on one syringe and in another syringe the stopper was twisted and would not allow the plunger to move.Event description per customer's email states, "i have two 10ml syringes with luer lok tip that has dislodged/disconnected black piece from the plunger.One lost all suction and ability to be used and one the black piece is twisted and will not allow plunger to move.".
 
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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 Key8608421
MDR Text Key148431668
Report Number2243072-2019-00914
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 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received04/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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