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 SYRINGE 0.3ML 31G 8MM; 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 SYRINGE 0.3ML 31G 8MM; PISTON SYRINGE Back to Search Results
Model Number 328438
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2021
Event Type  malfunction  
Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported: the bd syringe 0.3ml 31g 8mm experienced needle hub separation within the shield.The following information was provided by the initial reporter: consumer reported needle hub separated with the shield.
 
Manufacturer Narrative
D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/19/2021.H.6.Investigation: customer returned (1) loose 0.3ml bd insulin syringe.The consumer reported needle hub separated with the shield.The returned syringe was examined, and it was observed that the needle hub/shield assembly was detached from the barrel.No damage to the barrel tip was observed.A review of the device history record was completed for batch # 0153971 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted for out of spec shield pull.There was one (1) notification noted that did not pertain to the complaint.Capa#1630423 was initiated.H3 other text : see h.10.
 
Event Description
It was reported: the bd syringe 0.3ml 31g 8mm experienced needle hub separation within the shield.The following information was provided by the initial reporter: consumer reported needle hub separated with the shield.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SYRINGE 0.3ML 31G 8MM
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12849153
MDR Text Key283955882
Report Number1920898-2021-01216
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908438032
UDI-Public00382908438032
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
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 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328438
Device Catalogue Number328438
Device Lot Number0153971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-