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: BECTON DICKINSON MEDICAL SYSTEMS MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES; 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
 

BECTON DICKINSON MEDICAL SYSTEMS MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES; PISTON SYRINGE Back to Search Results
Model Number 192-N251S
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2022
Event Type  malfunction  
Event Description
It was reported that needles clogged/blocked while using mckesson prevent® sg glide safety hypodermic needles.This has occurred over 30 times; however, no patient impact reported.The following information was provided by the initial reporter: today i went thru 6 in a row that were not useable.We are not able to draw up medication with them or to expel air or medication thru them.We don¿t use these needles to draw up the medication.After we draw it up we change the needle and use one of these 25g 1 inch needles to inject the patient.In the beginning we did not realize we had a problem so we had some patients who had to be stuck twice when we could not get the medication to flow.We have had this happen with over 30-40 needles between the two boxes of the same lot number that we have opened so far.
 
Manufacturer Narrative
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 needles clogged/blocked while using mckesson prevent® sg glide safety hypodermic needles.This has occurred over 30 times; however, no patient impact reported.The following information was provided by the initial reporter: today i went thru 6 in a row that were not useable.We are not able to draw up medication with them or to expel air or medication thru them.We don¿t use these needles to draw up the medication.After we draw it up we change the needle and use one of these 25g 1 inch needles to inject the patient.In the beginning we did not realize we had a problem so we had some patients who had to be stuck twice when we could not get the medication to flow.We have had this happen with over 30-40 needles between the two boxes of the same lot number that we have opened so far.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-apr-2022.H6: investigation summary it is reported that unable to get fluid or air thru the needles.To aid in the investigation, eleven samples were received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution, all samples did not expel the solution; these needles are clogged.A device history record review was completed for provided material number 306616, columbus needle lot numbers 1214992, 1278946, 1214008, 1214997.These needle lots were used in the manufacturing of the final product lots 1341422.The review revealed there was documentation for this type of defect during the production run of lot number 1214992 for clogged needles due to silicone.It could be possible these samples are escapes from the incident that occurred while producing batch 1214992.The process to isolate affected product was reviewed, as well as the process of variations that could induce the needle clogged / blocked symptom.The processes were adjusted to prevent variations that could result in this defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLES
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13980797
MDR Text Key288902105
Report Number1213809-2022-00175
Device Sequence Number1
Product Code FMF
UDI-Device Identifier10612479248578
UDI-Public10612479248578
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number192-N251S
Device Catalogue Number306616
Device Lot Number1341422
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-