• 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 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 INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE Back to Search Results
Model Number 328418
Device Problems Break (1069); Defective Device (2588)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/22/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle missing, bending during use and breaks off during use on lot # 9091562. Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. If samples are received in the future the complaint will be reopened for further investigation. A review of the device history record was completed for batch# 9091562. All inspections were performed per the applicable operations qc specifications. There was one (1) notification [200815571] noted that did not pertain to the complaint. Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that bd insulin syringe with the bd ultra-fine¿ needle are damaged. This was discovered during use. The following information was provided by the initial reporter: material no: 328418 batch no: 9091562. It was reported that one syringe was missing the needle, hub was still attached to the syringe but needle was missing. Also stated that the needles bend when injecting and one needle broke off into the injection site during injection. Consumer was able to remove the needle with a tweezer. Verbatim: hello. I have been a diabetic for about 25 years and i use bd syringes for my insulin. Typically, i never have any issues with the syringes, however i wanted to make you aware of something which has recently occurred. Some syringes i've recently received from my pharmacy appear to be defective. I receive a box of 100 syringes and in a couple of the packages, the syringes are either missing the needles or, and this is worse, the needles will bend or break when i attempt an injection. This is definitely not a regular occurrence and it certainly won't prevent me from using your product! i just wanted to make someone aware of what happened. Thank you very much and i hope everyone has a wonderful day! per update in snow (b)(6) 2020. Consumer called back and provided additional information. Stated that one syringe was missing the needle, hub was still attached to the syringe but needle was missing. Also stated that the needles bend when injecting and one needle broke off into the injection site during injection. Consumer was able to remove the needle with a tweezer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
Type of DevicePISTON 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9655659
MDR Text Key194929813
Report Number1920898-2020-00064
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328418
Device Catalogue Number328418
Device Lot Number9091562
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2019
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: 01/31/2020 Patient Sequence Number: 1
-
-