• 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 INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 30GX1/2" INSULIN SYRINGE AND NEEDLE

  • 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 INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 30GX1/2" INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328466
Device Problems Break (1069); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165)
Event Date 05/11/2017
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Results: a sample is not available for evaluation. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6235614. In the event that new, changed, or corrected information is obtained, a supplemental report will be filed. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. (b)(4).
 
Event Description
It was reported that a needle of a bd insulin syringe with the bd ultra-fine¿ needle 0. 5ml 30gx1/2" broke off when a consumer inserted it into an insulin vial. The needle fell to the floor and the consumer stepped on it. She was evaluated by an orthopedic physician and received x-rays, but the needle was not removed. This has caused pain and discomfort with ambulation and the consumer is unable to walk. A shoe cushion was also inserted in the customer shoe.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.5ML 30GX1/2"
Type of DeviceINSULIN SYRINGE AND NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6614935
MDR Text Key76767314
Report Number1920898-2017-00068
Device Sequence Number1
Product Code FMF
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 consumer,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 05/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328466
Device Lot Number6235614
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/19/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/06/2017 Patient Sequence Number: 1
-
-