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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE
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BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
"unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.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.(b)(4).".
 
Event Description
It was reported that an unspecified number of unspecified bd syringes separated from the hub during use.The following was reported by the initial reporter: "it was reported that the needle remains in the orange cap and not affixed to the syringe.Verbatim: email have been using bd 1/2ml, ½", 30 gauge syringes for over 20 years.Recently i have found numerous defective syringes.Upon removal of the orange top the needle remains in the top rather than affixed to the syringe itself.(see attached photo) if it were a one time occurrence, i could understand it, but it has been happening all too often.".
 
Manufacturer Narrative
H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.One photo of a loose 0.5ml bd insulin syringe was provided.The customer reported upon removal of the orange top the needle remains in the top rather than affixed to the syringe itself.The photo was examined, and it was observed that the needle hub/shield assembly was separated from the barrel.No damage to the barrel tip was observed.Due to the batch being unknown, no dhr review can be completed.
 
Event Description
It was reported that an unspecified number of unspecified bd syringes separated from the hub during use.The following was reported by the initial reporter: "it was reported that the needle remains in the orange cap and not affixed to the syringe.Verbatim: email have been using bd 1/2ml, ½", 30 gauge syringes for over 20 years.Recently i have found numerous defective syringes.Upon removal of the orange top the needle remains in the top rather than affixed to the syringe itself.(see attached photo) if it were a one time occurrence, i could understand it, but it has been happening all too often.".
 
Event Description
It was reported that an unspecified number of unspecified bd syringes separated from the hub during use.The following was reported by the initial reporter: "it was reported that the needle remains in the orange cap and not affixed to the syringe.Verbatim: email have been using bd 1/2ml, ½", 30 gauge syringes for over 20 years.Recently i have found numerous defective syringes.Upon removal of the orange top the needle remains in the top rather than affixed to the syringe itself.(see attached photo) if it were a one time occurrence, i could understand it, but it has been happening all too often.".
 
Manufacturer Narrative
H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.One photo of a loose 0.5ml bd insulin syringe was provided.The customer reported upon removal of the orange top the needle remains in the top rather than affixed to the syringe itself.The photo was examined, and it was observed that the needle hub/shield assembly was separated from the barrel.No damage to the barrel tip was observed.Due to the batch being unknown, no dhr review can be completed.Capa#1830423 was initiated.
 
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Brand Name
UNSPECIFIED BD SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11362019
MDR Text Key233277624
Report Number2243072-2021-00536
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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