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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE WITH NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 309625
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/02/2018
Event Type  malfunction  
Manufacturer Narrative
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 bd¿ slip tip syringe had needle separation. There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields. This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacturer: no.
 
Event Description
It was reported that bd slip tip syringe had needle separation. There was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD¿ SLIP TIP SYRINGE WITH NEEDLE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key7718701
MDR Text Key115110877
Report Number1213809-2018-00463
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309625
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/25/2018 Patient Sequence Number: 1
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