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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO. SYRINGE, PISTON

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BECTON DICKINSON & CO. SYRINGE, PISTON Back to Search Results
Lot Number 8026690
Device Problems Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  No Answer Provided  
Event Description
Earlier my tech found some contaminated syringes bd 1 ml. These syringes are still sealed in their packaging. They have not been opened. The packaging are still intact. It looks like the contaminated products have the same lot number. It is lot 8026690, exp 01/31/2023. We are currently trying to look through our supply in our iv rooms and pull any of the products from this lot number. We alerted our mgmt and bd regarding this matter. (b)(6).
 
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Brand NameSYRINGE, PISTON
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON & CO.
MDR Report Key8208486
MDR Text Key132205107
Report NumberMW5082726
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number8026690
Was Device Available for Evaluation? No Answer Provided
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

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