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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 10ML LL
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BECTON DICKINSON, S.A. SYRINGE 10ML LL Back to Search Results
Catalog Number 305959
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
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 Description
It was reported that syringe 10ml ll package was damaged.This occurred on 9600 occasions.The following information was provided by the initial reporter: on delivery, the packages were broken and crushed, the packaging could no longer guarantee the sterility of the syringes.
 
Manufacturer Narrative
H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2103052, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.The complaint could not be confirmed and the root cause is undetermined.
 
Event Description
It was reported that syringe 10ml ll package was damaged.This occurred on 9600 occasions.The following information was provided by the initial reporter: on delivery, the packages were broken and crushed, the packaging could no longer guarantee the sterility of the syringes.
 
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Brand Name
SYRINGE 10ML LL
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key12125769
MDR Text Key263433912
Report Number3003152976-2021-00365
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 foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305959
Device Lot Number2103052
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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