MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 27X1/2; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305758
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	01/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device expiration date: unknown.(b)(6).Device manufacture date: unknown.Investigation summary: not applicable as no sample is returned.Investigation conclusion: unable to confirm the customer experience as no samples received for further evaluation.Root cause description: the reported defect cannot be confirmed as actual sample was not returned for evaluation.Therefore, root cause could not be determined.The complaint will be re-opened and re-investigated if the sample is returned.Rationale: the complaint will be tracked and monitored.
Event or Problem Description
It was reported that the needle eclipse 27x1/2 experienced a safety mechanism failure during use, and was involved in a dirty needle stick injury to the nurse.The nurse received unspecified lab testing as a result of the needle stick.It has since been confirmed that all results from the testing were negative.The following information was provided by the initial reporter: material no.305758, batch no.Unknown.Per email: chc complaint reference #: (b)(4).Cat# of product being complained: 305758 description of product: needle eclipse 27gx1/2 in f/ll syr 100ea/pk 12pk/ca.Lot or s/n: unsure.Complaint category: fail to function / defective.Reportable: no.Incident date: (b)(6) 2020.Hospital complaint reference #: details of complaint (reported issue): rn needle stick.She believes she may have locked the safety guard but not quite sure.Rn went to pick it up but stuck in left index finger.Complaint noticed: prior to use.Problem frequency: 1st time.Customer exposure:.Patient injury: no.Has health canada been informed? no.Qty affected: 1 ea.Samples available? no.Is customer requesting an rga?: no.On 01/22/2020: received email: was there any defect or issue with the actual needle? no.Was there any exposure to blood/bodily fluids? yes.Rn followed up with er and employee health.All lab results negative for patient and rn.If so, was there any medical intervention such as post lab testing, administration of anti-viral? see above.Are patient identifiers known? if so, please provide (gender, age, dob, weight, etc.) (b)(6) male, (b)(6), 172 cm,.

• Brand Name: NEEDLE ECLIPSE 27X1/2
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9672789
• Report Number: 8041187-2020-00054
• Device Sequence Number: 2923489
• Product Code: FMI
• UDI-Device Identifier: 30382903057581
• UDI-Public: 30382903057581
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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: Other
• Device Model Number: 305758
• Device Catalogue Number: 305758
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/05/2020
• 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: Other
• Patient Age: 64 YR