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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 100ML CATH TIP
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BECTON DICKINSON, S.A. SYRINGE 100ML CATH TIP Back to Search Results
Catalog Number 300605
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Pain (1994)
Event Date 12/23/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the syringe 100ml cath tip experienced molding defects -sharp protrusions.The following information was provided by the initial reporter: used for ear rinsing, wax removal.The separate attachment nozzle to the syringe is jagged and causes pain when placed in the ear.Most likely the boxes in the same batch had the same problem.The nozzle is not always used and thus the fault may have gone unnoticed.
 
Manufacturer Narrative
Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2005200, no deviations or non conformances were identified during the manufacturing process that could have contributed to this issue.Ten retained samples of lot 2005200 were used for additional evaluation.The product was visually inspected, no defects or damage was observed on any of the syringe tips.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Results from all inspections a were reviewed lot 2005200 and no issues were identified.Based on the available information we are not able to determine a root cause at this time.
 
Event Description
It was reported that the syringe 100ml cath tip experienced molding defects -sharp protrusions.The following information was provided by the initial reporter: used for ear rinsing, wax removal.The separate attachment nozzle to the syringe is jagged and causes pain when placed in the ear.Most likely the boxes in the same batch had the same problem.The nozzle is not always used and thus the fault may have gone unnoticed.
 
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Brand Name
SYRINGE 100ML CATH TIP
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
MDR Report Key11189538
MDR Text Key230243474
Report Number3002682307-2021-00018
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 distributor,foreign,other
Type of Report Initial,Followup
Report Date 04/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number300605
Device Lot Number2005200
Was Device Available for Evaluation? No
Date Manufacturer Received04/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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