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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 990687
Device Problem Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that foreign matter was visible in the bd plastipak¿ luer-lok¿ syringe after being used to aspirate morphine. As reported by the customer, "notivisa presence of fragment within the syringe after aspiration of morphine. Information received by email on (b)(6) 2019: there was no need for medical or surgical intervention. There was no damage to the patient or health professional. (b)(6) 2019.
 
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Brand NameBD PLASTIPAK¿ LUER-LOK¿ SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer (Section G)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8378851
MDR Text Key139047206
Report Number3003916417-2019-00150
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
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,Followup
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990687
Device Lot Number8270837
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2019
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? Yes
Date Device Manufactured09/27/2018
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: 02/28/2019 Patient Sequence Number: 1
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