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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD NORMAL SALINE FLUSH SYRINGES 3D ; SALINE, VASCULAR ACCESS FLUSH
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BECTON DICKINSON AND COMPANY BD NORMAL SALINE FLUSH SYRINGES 3D ; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Lot Number 8290-3065-46
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2019
Event Type  No Answer Provided  
Event Description
We received a new lot of bd normal saline flush syringes 10 ml (8290-3065-46) which had a new 3d/qr reader style barcode.We are on epic and do bedside barcode scanning and were not initially able to get this barcode to read despite multiple attempts (per their report 5 or more attempts by 3 nurses).Nursing then decided to stop using the barcode scanning feature and after about 40 attempts, we were able to get it to read in the pharmacy, but were not consistently able to recreate the scan.After another 5 mins of trial and error, we determined the scanner must be pointed at the top quarter of the barcode and the syringe oriented vertically (not horizontally) to get this to read properly.While nursing education has been provided, we feel this creates an unneeded safety issue moving forward and would like to see if (b)(4) can petition the mfr to return to the linear/2d barcode.(b)(4).Email: [email protected].Access number: (b)(4).
 
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Brand Name
BD NORMAL SALINE FLUSH SYRINGES 3D
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key8470882
MDR Text Key140898368
Report NumberMW5085439
Device Sequence Number1
Product Code NGT
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 03/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Lot Number8290-3065-46
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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