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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 300865
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
Results: 1 unused sample of 50ll without blister has been received. On visual inspection of the sample received no damage or molding defect can be observed in it. Plunger is moved manually not appreciating any defect in the syringe. Ten retained samples of 50ll lot 1708241 are evaluated. On visual inspection of these ten retained samples no damage no damage or molding defect can be observed in it. Plunger is moved manually not appreciating any defect in the ten syringes. Dhr of lot 1708241 has been reviewed not finding any annotation or deviation regarding the alleged defect. Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
 
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 the plunger on a bd plastipak¿ concentric luer lock syringe was difficult when drawing up medication. No injury or medical intervention.
 
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Brand NameBD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
Type of DeviceHYPODERMIC 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7100519
MDR Text Key269352129
Report Number3003152976-2017-00170
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 foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot Number1708241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2017
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: 12/08/2017 Patient Sequence Number: 1
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