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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON 1 ML TB SYRINGE

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BECTON DICKINSON 1 ML TB SYRINGE Back to Search Results
Lot Number 708642
Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)
Patient Problem No Code Available (3191)
Event Date 02/01/2018
Event Type  Injury  
Event Description
Twenty of 200 sterile bd 1 ml tb syringes with 1 inch needle, lot 7087642, were defectively packaged, such that the sterile barrier was compromised, making the product unusable. All product was labeled as being packaged in cavities 5 and 6.
 
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Brand Name1 ML TB SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key7320460
MDR Text Key101852119
Report NumberMW5075717
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 03/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2018
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number708642
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/06/2018 Patient Sequence Number: 1
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