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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 3-PIECE SYRINGE; PISTON SYRINGE
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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 3-PIECE SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 301189
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported that bd plastipak¿ 3-piece syringe had syringe pump alarms during use of the syringe.The following information was provided by the initial reporter: "recurring issues of occlusion alarms and high pressures when used with fresenius syringe pumps.".
 
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H6: 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.
 
Event Description
It was reported that bd plastipak¿ 3-piece syringe had syringe pump alarms during use of the syringe.The following information was provided by the initial reporter: "recurring issues of occlusion alarms and high pressures when used with fresenius syringe pumps.".
 
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Brand Name
BD PLASTIPAK¿ 3-PIECE 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 Key13446977
MDR Text Key285238164
Report Number3003152976-2022-00043
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSW
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 02/04/2022
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 Number301189
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/20/2022
Initial Date FDA Received02/03/2022
Supplement Dates Manufacturer Received02/04/2022
Supplement Dates FDA Received02/18/2022
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
Patient Sequence Number1
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