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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 Material Puncture/Hole (1504)
Patient Problem Needle Stick/Puncture (2462)
Event Date 12/03/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.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.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 needle pierced through shield.This was discovered before use.The following information was provided by the initial reporter: following our telephone conversation on tuesday (b)(6) 2019 at 10:15 am, the microfine syringe with the needle coming out of the protective cap.The bag was still in the cardboard box when i took it and the syringe in the original bag, and i pricked myself with it, hoping that no one would get pricked before me.
 
Manufacturer Narrative
H.6.Investigation summary no physical samples were received however the investigation was performed based on the photo provided.The reported issue was observed and based on trend analysis no further action is required at this time.No dhr review can be carried out as lot number is unknown.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.H3 other text : see section h.10.
 
Event Description
It was reported that unspecified bd¿ syringe needle pierced through shield.This was discovered before use.The following information was provided by the initial reporter: following our telephone conversation on tuesday (b)(6) 2019 at 10:15 am, the microfine syringe with the needle coming out of the protective cap.The bag was still in the cardboard box when i took it and the syringe in the original bag, and i pricked myself with it, hoping that no one would get pricked before me.
 
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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 Key9489362
MDR Text Key177151299
Report Number2243072-2019-02847
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Date Manufacturer Received12/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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