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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE; ANTISTICK SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE; ANTISTICK SYRINGE Back to Search Results
Model Number 305269
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/31/2021
Event Type  malfunction  
Event Description
It was reported bd integra syringe had an issue with leakage.The following information was provided by the initial reporter: "consumer reported that the syringe leaked during injection, stated that it leaked around the plunger rod as he was trying to depress the rod.".
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported bd integra syringe had an issue with leakage.The following information was provided by the initial reporter: "consumer reported that the syringe leaked during injection, stated that it leaked around the plunger rod as he was trying to depress the rod.".
 
Event Description
It was reported bd integra syringe had an issue with leakage.The following information was provided by the initial reporter: "consumer reported that the syringe leaked during injection, stated that it leaked around the plunger rod as he was trying to depress the rod.".
 
Manufacturer Narrative
D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/3/2021.H.6.Investigation: one 3ml integra syringe (p/n 305269) inside of a partially opened blisterpak from batch #9170766 was received.The sample was visually evaluated.The syringe was observed to be activated which makes it impossible to conduct pressure testing to confirm leakage past stopper testing.In lieu of the testing the inside barrel diameter was measured to ensure conformity and found to be within specification.The stopper of the syringe was also visually evaluated under light and magnification and found to have no visible deformities that would lead to leakage past stopper.Unused physical samples are needed to perform leakage past stopper testing to confirm the defect.Since the sample received did not display the reported condition a potential root cause could not be defined, and corrective actions are not necessary.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.
 
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Brand Name
BD INTEGRA SYRINGE
Type of Device
ANTISTICK SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12900239
MDR Text Key285393775
Report Number1213809-2021-00786
Device Sequence Number1
Product Code MEG
UDI-Device Identifier30382903052692
UDI-Public30382903052692
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011103
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number305269
Device Catalogue Number305269
Device Lot Number9170766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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