• 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 BD SHARPS DISPOSAL BY MAIL; 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 BD SHARPS DISPOSAL BY MAIL; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 323488
Device Problem Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/17/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is premium plastic solution.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date : unknown.A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 1 bd sharps disposal by mail container had no lid.The following information was provided by the initial reporter : material no.323488.Batch no.0255001.It was reported that lid was missing when preparing to return by mail for disposal.
 
Manufacturer Narrative
H.6.Investigation: 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.
 
Event Description
It was reported that 1 bd sharps disposal by mail container had no lid.The following information was provided by the initial reporter : material no.323488 batch no.0255001.It was reported that lid was missing when preparing to return by mail for disposal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SHARPS DISPOSAL BY MAIL
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11829672
MDR Text Key256728711
Report Number2243072-2021-01487
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
PMA/PMN Number
K943137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 06/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number323488
Device Lot Number0255001
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/17/2021
Initial Date FDA Received05/15/2021
Supplement Dates Manufacturer Received06/15/2021
Supplement Dates FDA Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-