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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD¿ PEN NEEDLES

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BD (SUZHOU) BD¿ PEN NEEDLES Back to Search Results
Catalog Number 329497
Device Problem Failure to Deliver (2338)
Patient Problem No Information (3190)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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¿ pen needles were clogged during injection.
 
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Brand NameBD¿ PEN NEEDLES
Type of DevicePEN NEEDLE
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8203871
MDR Text Key131716089
Report Number3006948883-2018-00323
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number329497
Device Lot Number7061488
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2017
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: 12/28/2018 Patient Sequence Number: 1
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