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 BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 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
 

BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB; PISTON SYRINGE Back to Search Results
Model Number 305924
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/05/2019
Event Type  malfunction  
Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: hypodermic single lumen needle.Medical device type: fmi.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8064678, medical device expiration date: 2023-02-28, device manufacture date: 2018-03-05, medical device lot #: 8119703, medical device expiration date: 2023-04-30, device manufacture date: 2018-04-29.Pma/510(k)#: k980987 / k951254.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It has been reported that the bd¿ syringe 3ml ll w/ndl sftygld 25x1 rb has been found containing an unknown liquid before use.The following has been provided by the initial reporter: it was reported that there is a gel like substance which seems to be lubricant in the syringe and on the stopper.Cn called stating that this seems to be a wide spread problem on going, that a lot of the syringes used at their facilities have the same volume of gel like substance which seems to be lubricant in the syringe and on the stopper.Ref no: 305924.Lot nos.8064678, 8119703.
 
Manufacturer Narrative
H.6.Investigation: one photo of a loose 3ml syringe with safetyglide needle attached was received and evaluated.It appeared the "gel-like" substance was silicone.The defect could not be confirmed based on the photo provided.It could not be determined if the amount of silicone present was excessive per product specification.A physical sample is required for a more thorough investigation.Please note that silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h.10.
 
Event Description
It has been reported that the bd¿ syringe 3ml ll w/ndl sftygld 25x1 rb has been found containing an unknown liquid before use.The following has been provided by the initial reporter: it was reported that there is a gel like substance which seems to be lubricant in the syringe and on the stopper.Cn called stating that this seems to be a wide spread problem on going, that a lot of the syringes used at their facilities have the same volume of gel like substance which seems to be lubricant in the syringe and on the stopper.Ref no (b)(4) lot nos.8064678, 8119703.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9505608
MDR Text Key195577397
Report Number1213809-2019-01290
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903059240
UDI-Public30382903059240
Combination Product (y/n)N
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number305924
Device Catalogue Number305924
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Date Manufacturer Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-