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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD ULTRASAFE PLUS X100L SYRINGE

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BECTON DICKINSON BD ULTRASAFE PLUS X100L SYRINGE Back to Search Results
Catalog Number 47513302
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Investigation summary: unconfirmed, no sample provided. Investigation conclusion: based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer but not correlate this symptom with a potential cause linked to bd process. Root cause description: full root cause analysis could not be conducted with the available information and is closed without a conclusion. Until samples are available no further investigation will be carried out. Batch record review did not indicate of any incident in relation to the problem statement. Batch was released in accordance to the acceptable criteria. Rationale: unconfirmed, no sample provided.
 
Event Description
It was reported that there was a loose plunger on the bd ultrasafe¿ plus x100l.
 
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Brand NameBD ULTRASAFE PLUS X100L
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON
faraday road
dorcan
swindon wiltshire SN3 5 JH
UK SN3 5JH
Manufacturer (Section G)
BECTON DICKINSON
faraday road
dorcan
swindon wiltshire SN3 5 JH
UK SN3 5JH
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8391183
MDR Text Key138215638
Report Number3001741852-2019-00003
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number47513302
Device Lot Number1703375
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/05/2019 Patient Sequence Number: 1
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