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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY 25 GAUGE X 1 INCH IMMUNIZATION NEEDLES SYRINGE, PISTON

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BECTON, DICKINSON AND COMPANY 25 GAUGE X 1 INCH IMMUNIZATION NEEDLES SYRINGE, PISTON Back to Search Results
Lot Number 931712
Device Problems Fluid Leak (1250); Material Separation (1562); Material Protrusion/Extrusion (2979); Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 09/14/2020
Event Type  malfunction  
Event Description
We have had multiple reports of 4 specific concerns with these needles. Some needles were bent upon opening the package. When the safety feature was engaged it bent so that the needle was sticking out (lot numbers 931712 and 0175200). After the flu vaccination was administered, the clinician was removing the needle, but the needle stayed in the patient's arm as it came apart from the hub. While administering a flu vaccination, the needle came apart from the hub and the vaccination spilled over the patient and clinician. (lot numbers 931712 and 0175200).
 
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Brand Name25 GAUGE X 1 INCH IMMUNIZATION NEEDLES
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton drive
franklin lakes NJ 07417
MDR Report Key10696908
MDR Text Key211887213
Report Number10696908
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/30/2020,09/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number931712
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2020
Event Location Other
Date Report to Manufacturer10/19/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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