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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
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BECTON DICKINSON, S.A. 50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGE Back to Search Results
Catalog Number 300223
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 150 50 ml bd plastipak¿ luer-lok¿ syringes experienced a molding defect with sharp protrusions.The following information was provided by the initial reporter: we present the defects found on the 50 ml syringes.The whole lot had a streak on the upper portion of the plunger.Metallic colored particles were found on 150 plungers.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-09-27.H6: investigation summary: samples and photos received for investigation, upon visual inspection of the pictures sent, it can be observed black foreign matter with a small size, in the plunger of the syringes.Pictures also show that this foreign matter can be removed.No foreign matter has been found in the samples sent once the syringes were inspected.No grease has been found in the device and the plunger do not have any greasy remain of foreign matter when it is touched.Foreign matter noticed in the pictures cannot be identified with evidence.A device history review was performed for reported lot 2008340, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.The assembly station has a de-ionizer and vacuum system used to remove any particles inside the barrel.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.The areas where pieces run in manufacturing area are protected to avoid damage on the product and reduce particles from generating.Possible root cause is associated with the assembly process.
 
Event Description
It was reported that 150 50 ml bd plastipak¿ luer-lok¿ syringes experienced a molding defect with sharp protrusions.The following information was provided by the initial reporter: we present the defects found on the 50 ml syringes.The whole lot had a streak on the upper portion of the plunger.Metallic colored particles were found on 150 plungers.
 
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Brand Name
50 ML BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12557625
MDR Text Key274255858
Report Number3003152976-2021-00648
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/04/2021
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 Number300223
Device Lot Number2008340
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/02/2021
Initial Date FDA Received09/30/2021
Supplement Dates Manufacturer Received11/04/2021
Supplement Dates FDA Received12/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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