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: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ 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
 

BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 324917
Device Problem Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/07/2023
Event Type  malfunction  
Event Description
It was reported that prior to use with an unspecified amount of bd ultra-fine¿ insulin syringe when removing shield the needle separated from device and remained in shield.This is the 2nd of 2 occurrences.The following information was provided by the initial reporter, translated from portuguese to english: customer contacts reporting a defect with the needles of the bd ultra fine syringe, where when removing the protective cap, the needles are stuck in the cap, making it impossible to use.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).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 prior to use with an unspecified amount of bd ultra-fine¿ insulin syringe when removing shield the needle separated from device and remained in shield.This is the 2nd of 2 occurrences.The following information was provided by the initial reporter, translated from portuguese to english: customer contacts reporting a defect with the needles of the bd ultra fine syringe, where when removing the protective cap, the needles are stuck in the cap, making it impossible to use.
 
Manufacturer Narrative
H6: investigation summary no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 9350261.All inspections and challenges were performed per the applicable operations qc specification.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 31-mar-2023.H6: investigation summary customer returned one loose syringe 0.5ml 31ga 6mm in an open polybag from lot#9350261.Customer reported that when removing the protective cap, the needles are stuck in the cap, making it impossible to use.The returned syringe was visually examined and found no damages and then shield was removed from the syringes and observed no needle or hub stuck to the shield.Hence, the alleged issue could not be confirmed.See attached photos.A review of the device history record was completed for batch# 9350261.All inspections and challenges were performed per the applicable operations qc specification.Embecta was not able to duplicate or confirm the customer¿s indicated issue.Root cause cannot be determined at this time as the issue is unconfirmed.
 
Event Description
It was reported that prior to use with an unspecified amount of bd ultra-fine¿ insulin syringe when removing shield the needle separated from device and remained in shield.This is the 2nd of 2 occurrences.The following information was provided by the initial reporter, translated from portuguese to english: customer contacts reporting a defect with the needles of the bd ultra fine syringe, where when removing the protective cap, the needles are stuck in the cap, making it impossible to use.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD ULTRA-FINE¿ INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key16482091
MDR Text Key310957959
Report Number1920898-2023-00086
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number324917
Device Lot Number9350261
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/25/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-