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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD SAFEASSIST¿ SAFETY PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON AND CO. BD SAFEASSIST¿ SAFETY PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 329917
Device Problem Inaccurate Information (4051)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2023
Event Type  malfunction  
Manufacturer Narrative
E.1.Initial reporter phone #: (b)(6).H.3.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 prior to use with 4000 bd safeassist¿ safety pen needle the pzn number on the product is incorrect.The following information was provided by the initial reporter, translated from german to english: claimed wrong pzn printed on the package.
 
Manufacturer Narrative
H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.A capa was raised to address this issue.
 
Event Description
It was reported that prior to use with 4000 bd safeassist¿ safety pen needle the pzn number on the product is incorrect.The following information was provided by the initial reporter, translated from german to english: claimed wrong pzn printed on the package.
 
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Brand Name
BD SAFEASSIST¿ SAFETY PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer (Section G)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17283577
MDR Text Key318769837
Report Number9616656-2023-00707
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number329917
Device Lot Number3010167
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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