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 Code	No Patient Involvement (2645)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Device expiration date: unknown.Device manufacture date: unknown.(b)(4).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.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Investigation conclusion: unable to confirm the customer experience as no photo / sample is received for investigation.End user risk assessment: based on 15 months complaint trending (from period of jun 2019 to aug 2020), there are 52 complaints for safety mechanism failure.As per p-eura document, (b)(4), the severity for safety mechanism failure is severe (s4) occurrence for safety mechanism failure.(total safety mechanism failure complaints in 15 months / 15 months sales volume) x 1,000,000.(52 / 310,747,922) x 1,000,000 = 0.167 ipm which is improbable (o1).The risk is acceptable per ms-qs-034.Root cause description: no photo/ sample were returned for investigation.Root cause could not be determined.The complaint will be re-opened and re-investigated if the sample is returned.Rationale: the complaint will continued to be tracked and monitored.
Event or Problem Description
It was reported that an unspecified number of syringes 1ml ll w/ndl eclipse 27x1/2 rb experienced safety mechanism failure after use.The following information was provided by the initial reporter: material no.305789; batch no.Unknown.Complaint 3 of 5.I have now had 2 staff with needle sticks related to malfunctioning safety shields on the bd eclipse 27g x ½" needle (ref 305789), 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).Thank you for your help on this important issue.

• 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: 10554527
• Report Number: 8041187-2020-00589
• Device Sequence Number: 3161478
• 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
• Report Date (Section B): 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/18/2020
• 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