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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
It was reported when using the bd plastipak¿ concentric luer lock syringe, the device tip was deformed curving upward.The following information was provided by the initial reporter.The customer stated: syringe with curved tip.This makes it unusable.
 
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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 21-mar-2022.H.6.Investigation: one sample was provided to our quality team for investigation.Through visual inspection of the product, the tip was observed to be molded incorrectly, it was curved and slightly deformed.A device history review was performed for reported lot 2108114, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Molding process parameters were reviewed and were verified to be within required limits.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.Based on our quality team's investigation, we are not able to identify a definitive root cause at this time.
 
Event Description
It was reported when using the bd plastipak¿ concentric luer lock syringe, the device tip was deformed curving upward.The following information was provided by the initial reporter.The customer stated: syringe with curved tip.This makes it unusable.
 
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Brand Name
BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13588496
MDR Text Key286646202
Report Number3003152976-2022-00079
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2108114
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2021
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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