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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD 3 ML SYRINGE SYRINGE, PISTON

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BD BD 3 ML SYRINGE SYRINGE, PISTON Back to Search Results
Catalog Number 309578
Device Problems Difficult to Remove (1528); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/23/2019
Event Type  malfunction  
Event Description
Contaminant in bd 3 ml syringe, lot #9140817, item#(b)(4). There was no difficulty in drawing the medication into the syringe; however, when the nurse attempted to remove the needle from the syringe, she was unable to do so. The medical director was in the bay, and he was able to remove the needle. When he did so, he noted a foreign contaminant in the syringe at the intersection of the syringe contacting the hub of the needle. All syringes from the above-noted lot were immediately removed, and the bd rep was contacted. The syringe was taken to our lab director. Viewed under the microscope, the contaminant did not appear to be fungal. The lab director, using a sterile needle, removed a small portion of the contaminant and placed it on blood agar to culture. At 24-hours, it has not grown anything. It will be observed another 24 hours. Fda safety report id# (b)(4).
 
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Brand NameBD 3 ML SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BD
MDR Report Key9245696
MDR Text Key164325003
Report NumberMW5090715
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
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309578
Device Lot Number9140817
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

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