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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

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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 25X1 RB; PISTON SYRINGE Back to Search Results
Catalog Number 305270
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe integra 3ml w/ndl 25x1 rb leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that vaccine is leaking out of the syringe down her customers arm as she is giving the shot.
 
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.H3 other text : see h10.
 
Event Description
It was reported that syringe integra 3ml w/ndl 25x1 rb leaked.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that vaccine is leaking out of the syringe down her customers arm as she is giving the shot.
 
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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 Key12543356
MDR Text Key273767080
Report Number1213809-2021-00673
Device Sequence Number1
Product Code MEG
UDI-Device Identifier00382903052707
UDI-Public00382903052707
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 09/29/2021
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
Device Operator Other
Device Catalogue Number305270
Device Lot Number0266457
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/31/2021
Initial Date FDA Received09/28/2021
Supplement Dates Manufacturer Received09/29/2021
Supplement Dates FDA Received10/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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