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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE Back to Search Results
Catalog Number 301229
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that a bd plastipak¿ 30ml luer-lock syringe has difficult plunger movement, during use. There was no report of exposure, injury or medical intervention.
 
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Brand NameBD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE
Type of DeviceSYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7599106
MDR Text Key111447613
Report Number3003152976-2018-00239
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2021
Device Catalogue Number301229
Device Lot Number1612258P
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2017
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: 06/13/2018 Patient Sequence Number: 1
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