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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD ULTRA-FINE¿ SYRINGE 31G X 6MM SYRINGE WITH NEEDLE

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BECTON DICKINSON DE MEXICO BD ULTRA-FINE¿ SYRINGE 31G X 6MM SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 326786
Device Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2017
Event Type  malfunction  
Manufacturer Narrative
Results: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A device history review was not conducted because a lot number could not be determined. Conclusion: bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received to confirm the stated defect.
 
Manufacturer Narrative
Original mdr reported incorrect "date received by manufacturer". The correct date is 08/01/2017.
 
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that there was a bd ultra-fine¿ syringe 31g x 6mm with a plunger that was difficult to pull. There was no report of medical intervention or serious injury.
 
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Brand NameBD ULTRA-FINE¿ SYRINGE 31G X 6MM
Type of DeviceSYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6808342
MDR Text Key249767173
Report Number9614033-2017-00002
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326786
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 Received08/01/2017
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: 08/21/2017 Patient Sequence Number: 1
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