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 SYRINGE INTEGRA 3ML W/NDL 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 SYRINGE INTEGRA 3ML W/NDL 25X1 RB; PISTON SYRINGE Back to Search Results
Model Number 305270
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/23/2020
Event Type  malfunction  
Manufacturer Narrative
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 was reported that a syringe integra 3ml w/ndl 25x1 rb was missing a cap and stuck the customer.The following information was provided by the initial reporter: "it was reported the customer was stuck with a needle that did not have a cap on it when it was received.Verbatim: customer was stuck with a needle that didn't have a cap on it.It was shipped without the cap.Customer is saying that she went to the er and they advised that she be placed on hiv medication as a preventative but she is hesitant because she is pregnant.The er did blood work and will monitor her but she was wondering if bd would pay for her medical bills.".
 
Event Description
It was reported that a syringe integra 3ml w/ndl 25x1 rb was missing a cap and stuck the customer.The following information was provided by the initial reporter: "it was reported the customer was stuck with a needle that did not have a cap on it when it was received.Verbatim: customer was stuck with a needle that didn't have a cap on it.It was shipped without the cap.Customer is saying that she went to the er and they advised that she be placed on hiv medication as a preventative but she is hesitant because she is pregnant.The er did blood work and will monitor her but she was wondering if bd would pay for her medical bills.".
 
Manufacturer Narrative
H.6.Investigation summary one photo was received and evaluated for catalog 305270 lot 6299513.The photo depicted a single packaged integra syringe.Only half of the package was visible in the photo.It was not clear whether the package had been opened or still sealed as the whole package was not visible.The syringe inside had no shield present over the needle.The stopper appeared to be at the breakout position, suggesting that the syringe was likely unused.Based on the partial package photo provided, it is possible that the potential root cause for the missing shield defect is associated with the assembly process.A photo of the entire package would be preferable for a better evaluation.Physical sample is necessary for better investigation of a potential root cause.No corrective actions are necessary based on the defective rate identified.A device history review was conducted for lot number 6299513.Batch 6299513 is considered in compliance with our product specification requirements.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE INTEGRA 3ML W/NDL 25X1 RB
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key9834024
MDR Text Key184161040
Report Number1213809-2020-00189
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052708
UDI-Public30382903052708
Combination Product (y/n)N
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 03/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Model Number305270
Device Catalogue Number305270
Device Lot Number6299513
Was Device Available for Evaluation? No
Date Manufacturer Received02/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-