Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320109
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2023
Event Type  malfunction  
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd ultra-fine¿ short pen needles cap does not attach.The following was received from the initial reporter: consumer reported finding the needle covers falling off the needle.Caller is storing the needle on the pen in his travel case date of event unknown date of event.
 
Manufacturer Narrative
H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time h3 other text : see h.10.
 
Event Description
It was reported that the bd ultra-fine¿ short pen needles cap does not attach.The following was received from the initial reporter: consumer reported finding the needle covers falling off the needle.Caller is storing the needle on the pen in his travel case.Date of event unknown date of event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD ULTRA-FINE¿ SHORT PEN NEEDLES
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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key18271324
MDR Text Key329807421
Report Number9616656-2023-01234
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number320109
Device Lot Number2333514
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-