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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3 ML SYRINGE LUER-LOK¿

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BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3 ML SYRINGE LUER-LOK¿ Back to Search Results
Catalog Number 309658
Device Problems Bent (1059); Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/24/2017
Event Type  malfunction  
Manufacturer Narrative
Dhr review for batch 7120876: manufacturing dates: 05/14/2017 ¿ 05/15/2017. Batch quantity was (b)(4). All visual inspections were performed as per requirement with no quality notifications related to the complaint defect. Batch 7120876 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment. No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Conclusion: without a sample, 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
Initial reporter phone #: (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 the tip was found bent on a bd plastipak¿ 3 ml syringe luer-lok¿. In addition, the flask was ¿oblique¿ making it difficult to ensure volume accuracy. There was no report of injury or medical intervention.
 
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Brand NameBD PLASTIPAK¿ 3 ML SYRINGE LUER-LOK¿
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7136181
MDR Text Key267825711
Report Number1213809-2017-00352
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K110771
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 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309658
Device Lot Number7120876
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 Received11/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/30/2017
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: 12/20/2017 Patient Sequence Number: 1
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