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 UNSPECIFIED BD INSULIN SYRINGE; 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 UNSPECIFIED BD INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Volume Accuracy Problem (1675)
Patient Problem Insufficient Information (4580)
Event Date 07/07/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that the scale markings on the unspecified bd¿ insulin syringe were incorrectly graduated.The following information was provided by the initial reporter, translated from spanish to english: "i have a complaint about the graduation of your brand's syringes, i preferred them since they are the best to administer and manipulate insulin, but a few days ago i noticed a lack of glucose control in my patient and today when i administered his dose i realize that the syringe is wrongly graduated.The first line comes to the edge in some syringes, in others it is well located, in others lower.I imagine that if you have any idea that the doses must be exact and thanks to their poor quality can generate a health problem for whoever is using them.".
 
Manufacturer Narrative
Investigation: customer returned an image of two syringes.The scale markings are present but not immediately flush with the uppermost tip of the body of the syringe.The markings do not appear to be significantly off-center.These markings would require proper measurement to ensure that they fell within specifications.However, since they were not returned for investigation, the samples cannot be measured.Due to the batch being unknown, no dhr review can be completed.Based on the image received, bd was unable to confirm the customer¿s indicated failure of glucose levels issues since the samples could not be measured directly to ensure they are within specifications.H3 other text.
 
Event Description
It was reported that the scale markings on the unspecified bd¿ insulin syringe were incorrectly graduated.The following information was provided by the initial reporter, translated from spanish to english: "i have a complaint about the graduation of your brand's syringes, i preferred them since they are the best to administer and manipulate insulin, but a few days ago i noticed a lack of glucose control in my patient and today when i administered his dose i realize that the syringe is wrongly graduated.The first line comes to the edge in some syringes, in others it is well located, in others lower.I imagine that if you have any idea that the doses must be exact and thanks to their poor quality can generate a health problem for whoever is using them.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNSPECIFIED BD INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key12277985
MDR Text Key265206516
Report Number2243072-2021-02023
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 08/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-