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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2023
Event Type  malfunction  
Event Description
It was reported that the syringe pump alarms while using the bd plastipak¿ syringes.The following was translated from dutch to english: the syringes indicate high pressure in our perfusor syringe pumps, when the syringe is changed for another syringe (same kind), the message often does not return.So it seems that some syringes give more resistance than others.
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 27-sep-2023.H.6.Investigation summary: several samples were provided to our quality team for investigation.The products were visually inspected.No damage of defects were observed, stoppers were verified to be properly assembled, and the plunger moved without issue.A device history review was performed for reported lots 2305115, 2306728 and 2306736, no deviations or non-conformances related to this issue were identified during the manufacturing process.Lubricant is employed during the syringe assembly process, the silicone helps facilitate easier movement of the plunger and stopper.The silicone employed in this product is a medical grade silicone authorized for product use.Throughout the manufacturing process, force testing and silicone content tests are conducted for each lot to evaluate the plunger movement and ensure the proper quantity of silicone within the product.Testing results were reviewed for lots 2305115, 2306728 and 2306736 and all results were found 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 the available information we are not able to determine a root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
 
Event Description
It was reported that the syringe pump alarms while using the bd plastipak¿ syringes.The following was translated from dutch to english: the syringes indicate high pressure in our perfusor syringe pumps, when the syringe is changed for another syringe (same kind), the message often does not return.So it seems that some syringes give more resistance than others.
 
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Brand Name
BD PLASTIPAK¿ SYRINGES
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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17736938
MDR Text Key323282719
Report Number3003152976-2023-00383
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 10/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number2306736
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/11/2023
Was Device Evaluated by Manufacturer? Yes
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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