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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1 RB; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1 RB; PISTON SYRINGE Back to Search Results
Catalog Number 309572
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/15/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1 rb had an improper seal.The following information was provided by the initial reporter: it was reported that several syringes that have not had an adequate seal.Verbatim: we have had several syringes that have not had an adequate seal.This has caused issues drawing patient doses, as well as administering patient doses.One of our end users reported that the dose leaked out of the syringe due to improper seal.
 
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Brand Name
SYRINGE 3ML LL W/NDL 22X1 RB
Common Device Name
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key12302789
Report Number1213809-2021-00554
Device Sequence Number3718625
Product Code FMF
UDI-Device Identifier00382903095728
UDI-Public00382903095728
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
K980987
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source other,user facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Other
Device Expiration Date12/31/2025
Device Catalogue Number309572
Device Lot Number1012676
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2021
Initial Report FDA Received Date08/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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