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 SYRINGE 0.5ML 31GA 6MM; 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 SYRINGE 0.5ML 31GA 6MM; PISTON SYRINGE Back to Search Results
Catalog Number 324911
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 2 bd syringe 0.5ml 31ga 6mm had shield attachment and bowed barrel issues.The following information was provided by the initial reporter :   the consumer reported the needle shields are difficult to remove and the barrel is bent prior to the injection.  date of event: unknown.Samples: yes.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-05-24.H6: investigation summary: customer returned three syringes, all with 0.5ml graduation markings.No pouch was returned for identification.Visual inspection found that two of the three syringes appeared to have been bent, one significantly so.The location of the bending is around the needle hub in both syringes.Two samples received shield pull force testing.The pull forces required to remove the needle shields were 4.00 lbs for the unbent sample, and 5.28 lbs for the slightly bent sample.The significantly bent sample was too damaged to properly fit on the available test fixture.An attempt was made to remove this needle shield by hand, but it remained in place.The bent sections are potentially the result of significant forces applied to the syringe as a result of difficulties encountered while attempting to remove the needle shield.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.Two of the samples were within specification with one approaching the upper limit.The significantly damaged syringe could not be tested but the pull force required to remove the needle shield is believed to be high based on the amount of force applied in an attempt to remove it.None of the samples disassembled during testing.A review of the device history record was completed for batch# 1012867.All inspections and challenges were performed per the applicable operations qc specifications.There were six (6) notifications noted that did not pertain to the complaint.Based on the samples received, bd was able to replicate or confirm the customer¿s indicated failure of the barrels bending in two of the three returned samples.Based on the samples received, bd was able to replicate or confirm the customer¿s indicated failure of the shield not detaching as intended.
 
Event Description
It was reported that 2 bd syringe 0.5ml 31ga 6mm had shield attachment and bowed barrel issues.The following information was provided by the initial reporter : the consumer reported the needle shields are difficult to remove and the barrel is bent prior to the injection.Date of event: unknown.Samples: yes.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE 0.5ML 31GA 6MM
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key11953603
MDR Text Key257433237
Report Number1920898-2021-00645
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 06/24/2021
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 Lay User/Patient
Device Catalogue Number324911
Device Lot Number1012867
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Initial Date Manufacturer Received 05/11/2021
Initial Date FDA Received06/07/2021
Supplement Dates Manufacturer Received06/15/2021
Supplement Dates FDA Received07/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-