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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 06/09/2023
Event Type  malfunction  
Manufacturer Narrative
H3.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 the bd safeassist¿ safety pen needle pzn number on the product is incorrect.The following information was provided by the initial reporter: customer complained about wrong pzn number on product.
 
Event Description
It was reported that the bd safeassist¿ safety pen needle pzn number on the product is incorrect.The following information was provided by the initial reporter: customer complained about wrong pzn number on product.
 
Manufacturer Narrative
H6: investigation summary one photo of a 30g x 8mm safe assist carton was returned from lot.No.3010167, cat.No.329917.Visual examination of the returned photo was carried out and an incorrect pzn code was observed.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.This complaint was confirmed to be a packaging graphics error therefore a review of the packaging process at the site is not required.Root cause will be determined as part of a capa.
 
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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
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17231670
MDR Text Key318355212
Report Number9616656-2023-00672
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 Received06/29/2023
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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