• 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 1/2ML W/NDL 27X1/2 RB 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 1/2ML W/NDL 27X1/2 RB PISTON SYRINGE Back to Search Results
Model Number 305620
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 02/13/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that an unspecified number of syringe 1/2ml w/ndl 27x1/2 rb were involved with dirty needle stick injuries after use. It has not been specified what, if any, medical intervention was administered or received as a result of the dirty needle stick injury. The following information was provided by the initial reporter: material no. : 305620, batch no. : unknown. Verbatim: our customer is having a large uptick in needle stick occurrences due to a safety needle not being available on our. 5ml. Most have occurred after injection. The most recent was before. The nurse had a difficult time removing the cap and stuck herself. From what i can tell the needle sticks have been to nurses. Below is the information from pharmacy. These syringes are used for very small doses of lovenox. Maximum 0. 5ml size (larger syringes have greater potential for overdose and cannot draw up to the 0. 01ml graduations as accurately. Can visualize the smaller amounts without uncapping. The syringes have a large cap that covers the first 0. 1ml graduations. The pharmacists would be unable to check the smaller doses we typically see with these patients.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 1/2ML W/NDL 27X1/2 RB
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 Key9786909
MDR Text Key186009596
Report Number1920898-2020-00203
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number305620
Device Catalogue Number305620
Device Lot NumberUNKNOWN
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 Received02/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/04/2020 Patient Sequence Number: 1
-
-