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U.S. Department of Health and Human Services

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

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BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP SYRINGE CONVENTIONAL SYRINGE Back to Search Results
Catalog Number 309623
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2018
Event Type  malfunction  
Manufacturer Narrative
The date received by manufacturer has been used for this field. 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 before use a bd¿ slip tip syringe with attached needle malfunctioned as ¿the needles don't stay on the syringe. ¿ there was no report of exposure, injury or medical intervention needed.
 
Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination. We were unable to fully investigate this incident. Lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. 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. Investigation conclusion: based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures. No root cause can be determined.
 
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Brand NameBD¿ SLIP TIP SYRINGE
Type of DeviceCONVENTIONAL SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7353963
MDR Text Key103042374
Report Number1213809-2018-00186
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096238
UDI-Public30382903096238
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309623
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/20/2018 Patient Sequence Number: 1
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