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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 20ML LL S/C 50; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO SYRINGE 20ML LL S/C 50; PISTON SYRINGE Back to Search Results
Catalog Number 303310
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2021
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.
 
Event Description
It was reported that the syringe 20ml ll s/c 50 packaging tore while opening it, leaving paper shards in the sterile field.The following information was provided by the initial reporter: "problem with the packaging, does not open properly.Paper tears risking contamination of sterile field".
 
Event Description
It was reported that the syringe 20ml ll s/c 50 packaging tore while opening it, leaving paper shards in the sterile field.The following information was provided by the initial reporter: "problem with the packaging, does not open properly.Paper tears risking contamination of sterile field.".
 
Manufacturer Narrative
The following fields were corrected due to additional information: d10: device available for eval no.D10: returned to manufacturer on: na.H1 device return to manuf.? no.H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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
SYRINGE 20ML LL S/C 50
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
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55 59 99 8400, k.m. 37.5
cuautitlan izcalli
MDR Report Key11441184
MDR Text Key243028933
Report Number9614033-2021-00024
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K151766
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303310
Device Lot Number0098737
Was Device Available for Evaluation? No
Date Returned to Manufacturer03/05/2021
Date Manufacturer Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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