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 DE MEXICO SYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF; PISTON SYRINGE
  • 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 DE MEXICO SYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF; PISTON SYRINGE Back to Search Results
Catalog Number 326779
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter last name: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 40 syringe insulin 0.5ml 31ga 8mm w10 self experienced a mix of product in a pack before use.The following was reported by the initial reporter: "the customer farmacos rejected us a box because the material of the box does not match the internal.".
 
Manufacturer Narrative
H6: investigation summary during the documentary review, no quality events records were found during the packaging product, the batch were inspected and later released in accordance with the valid work instruction based on the photographs received, it can be concluded that the code on the label of the corrugated box does not match the code of the individual box, however, it is not possible to confirm the product mix as there is no physical sealed evidence h3 other text : see h10.
 
Event Description
It was reported that 40 syringe insulin 0.5ml 31ga 8mm w10 self experienced a mix of product in a pack before use.The following was reported by the initial reporter: "the customer farmacos rejected us a box because the material of the box does not match the internal.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE INSULIN 0.5ML 31GA 8MM W10 SELF
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
MDR Report Key11377004
MDR Text Key233591035
Report Number9614033-2021-00021
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 04/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number326779
Device Lot Number0177661
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-