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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 301229
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: one photo received for investigation, upon visual inspection of the picture from lot 2006206 it can be observed a hair across the blister of the device. This suggest, the hair fell during packaging process, as it is located between film and paper of unitary packaging. A device history review was performed for reported lot 2006206, 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. While we cannot identify a direct issue, possible root cause is human error. Manufacturing personnel have been notified of this incident to increase awareness of this matter. A project was initiated to reduce any foreign matter inside our products. Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.
 
Event Description
It was reported when using the bd plastipak¿ luer-lok¿ syringe, the device experienced sterility issues (product not sterile). The following information was provided by the initial reporter. The customer stated: sealed hair in packaging.
 
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Brand NameBD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Type of DevicePISTON 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 Key12746670
MDR Text Key284839579
Report Number3003152976-2021-00726
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number301229
Device Lot Number2006206
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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