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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 20ML E/T PISTON SYRINGE

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BECTON DICKINSON, S.A. SYRINGE 20ML E/T PISTON SYRINGE Back to Search Results
Catalog Number 300613
Device Problem Inappropriate Audible Prompt/Feedback (2280)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/13/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no photos or physical samples that display the reported condition were available for investigation. Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device. As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated. Based on the available information we are not able to identify a root cause at this time. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that syringe 20ml e/t had a resistance building up in the syringe. The following information was provided by the initial reporter: we have received several complaints from the clinic that the 20ml syringes from you are showing increased problems with our pumps and are repeatedly not working. We have checked everything possible and came to the conclusion that there is obviously a greater resistance building up in the syringe.
 
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Brand NameSYRINGE 20ML E/T
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 Key12453304
MDR Text Key270812041
Report Number3003152976-2021-00593
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300613
Device Lot NumberUNKNOWN
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 Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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