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

Model Number	305789
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	07/09/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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).
Event or Problem 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).
Additional Manufacturer Narrative
Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h.10.

• Brand Name: SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10554530
• Report Number: 8041187-2020-00590
• Device Sequence Number: 19770529
• Product Code: FMF
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other