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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB PISTON SYRINGE

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BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB PISTON SYRINGE Back to Search Results
Model Number 305789
Device Problem Material Protrusion/Extrusion (2979)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Date 07/09/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. (b)(4).
 
Event Description
It was reported that 2 syringe 1ml ll w/ndl eclipse 27x1/2 rb experienced a safety mechanism failure resulting in a dirty needle stick injury. Product defect occurred after use. It has not been specified whether medical intervention was administered as a result of the dirty needle stick. The following information was provided by the initial reporter: material no. 305789, batch no. Unknown. I have now had 2 staff with needle sticks related to malfunctioning safety shields on the bd eclipse 27g x ½" needle, plus others who have expressed concerns but were not stuck. Unfortunately, none of them provided a lot number or expiration date, however i believe all of the concerns have arisen in the last month or two, if that helps. Concerns have included: after the safety shield was engaged, the needle bent and poked out the side of the shield. The rn heard the shield click and it appeared to be engaged but then it disengaged/flipped down leaving the needle exposed. The safety shield bent & cracked when engaged, leaving the needle exposed the shield fell off. I know nurses have also expressed that the flip-up shield safety feature is more challenging to engage and leaves more room for a needle-stick injury than a safety device that engages automatically following injection (such as a pop-up shield that is activated by depressing the plunger).
 
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Brand NameSYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10554530
MDR Text Key207601962
Report Number8041187-2020-00590
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number305789
Device Catalogue Number305789
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/18/2020 Patient Sequence Number: 1
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