MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD LUER-LOK SYRINGE WITH DETACHABLE BD ECLIPSE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

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	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: common device name: piston syringe.Medical device type: fmf.Medical device expiration date: unknown.There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k941562 (syringe).Pma / 510(k)#: k161170 (needle).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.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 (b)(4).The risk is acceptable per (b)(4).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 the bd luer-lok¿ syringe with detachable bd eclipse¿ needle safety mechanism failed and the nurse was stuck with the dirty needle after use.As a result, the nurse went to the emergency department to have labs drawn.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "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)" "on (b)(6) 2020 a nurse engaged the safety shield and heard it click, but when transporting it to the sharps container she was stuck by the needle.When the nurse looked closer at it, she noted that the safety shield was bent and cracked.The other concerns i mentioned did not result in needle stick injuries.In both of these needle stick cases, the nurses followed our organizational policy and went to the emergency department to have labs drawn to determine potential exposure to (b)(6).".

• Brand Name: BD LUER-LOK SYRINGE WITH DETACHABLE BD ECLIPSE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10625571
• Report Number: 8041187-2020-00640
• Device Sequence Number: 16986117
• Product Code: FMI
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• 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): 09/17/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/05/2020
• 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: Required Intervention