• 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 WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE; SYRINGE WITH HYPODERMIC 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¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE; SYRINGE WITH HYPODERMIC NEEDLE Back to Search Results
Catalog Number 305945
Device Problems Hole In Material (1293); Structural Problem (2506)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that ten "dirty needle stick injuries" occurred to individual nurses while using bd syringe with permanently attached safetyglide needle due to the safety guard "sticking." there was no report of treatment or medical intervention.
 
Manufacturer Narrative
No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A dhr check was not performed as the lot number is "unknown" for this complaint.Based on the samples / photo(s) 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD¿ SYRINGE WITH PERMANENTLY ATTACHED SAFETYGLIDE¿ NEEDLE
Type of Device
SYRINGE WITH HYPODERMIC NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7444831
MDR Text Key106003924
Report Number1920898-2018-00249
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903059455
UDI-Public30382903059455
Combination Product (y/n)N
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 05/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue Number305945
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 03/27/2018
Initial Date FDA Received04/19/2018
Supplement Dates Manufacturer Received03/27/2018
Supplement Dates FDA Received05/09/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-