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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE

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BECTON DICKINSON AND CO. SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE Back to Search Results
Catalog Number 328468
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter zip code : unknown. Investigation summary : exec summary - no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot. Capa/sa - based on the investigation, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time. Dhr review - a review of the device history record was completed for batch# 0321244. All inspections and challenges were performed per the applicable operations qc specifications.
 
Event Description
It was reported that 1 bd syringe 0. 5ml 31ga 8mm plunger end was unformed. The following information was provided by the initial reporter : material no: 328468 batch no: 0321244. Consumer reported the end of the plunger is not completely formed. Date of event unknown. Sample status unknown.
 
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Brand NameSYRINGE 0.5ML 31GA 8MM
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer (Section G)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11893465
MDR Text Key255466603
Report Number9616656-2021-00593
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328468
Device Lot Number0321244
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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