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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
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BECTON DICKINSON AND CO. BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE Back to Search Results
Catalog Number 329605
Device Problem Difficult or Delayed Activation (2577)
Patient Problems Needle Stick/Puncture (2462); Underdose (2542)
Event Date 01/30/2020
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that bd autoshield¿ duo safety pen needle did not retract back after injection.This was discovered during use.The following information was provided by the initial reporter: planned visit for insulin administration.When administering patients insulin, patient advised that they had not felt the needle pierce their skin.When i removed the needle from the patient's abdomen, it had not retracted back and therefore i was unsure if the dose of insulin had been administered or not.Faulty needle.Prime of the needle was performed prior to administration and insulin was coming out of the end of the needle therefore no concerns regarding needle were identified prior to administration.Patient stated his abdomen was sticky and therefore it is possible that the insulin did not enter his body.Details of injury (to patient, carer or healthcare professional): patient's blood glucose levels appeared stable despite incident.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier).Liaised with gp who advised to return 4 hours later (evening) to recheck blood glucose levels, if still high to administer usual dose of evening insulin as per protocol.Advised patient to contact hospital's single point of access if they began to feel unwell prior to their planned late visit.
 
Manufacturer Narrative
Investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.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.Based on the above, no additional investigation and no corrective/preventative action (capa) is required at this time.
 
Event Description
It was reported that bd autoshield¿ duo safety pen needle did not retract back after injection.This was discovered during use.The following information was provided by the initial reporter: planned visit for insulin administration.When administering patients insulin, patient advised that they had not felt the needle pierce their skin.When i removed the needle from the patient's abdomen, it had not retracted back and therefore i was unsure if the dose of insulin had been administered or not.Faulty needle.Prime of the needle was performed prior to administration and insulin was coming out of the end of the needle therefore no concerns regarding needle were identified prior to administration.Patient stated his abdomen was sticky and therefore it is possible that the insulin did not enter his body.
 
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Brand Name
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
Type of Device
PEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
MDR Report Key9849977
MDR Text Key191684314
Report Number9616656-2020-00240
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number329605
Device Lot NumberUNKNOWN
Date Manufacturer Received02/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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