MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305781
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510k: k980987 / k161170.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the syringe 3ml ll w/ndl eclipse 25x5/8 rb has been found experiencing safety mechanism failure during use.The following has been provided by the initial reporter: it was reported that the health care provider received a needle stick injury after the safety shield broke off.Verbatim: issue with 3ml 25g 5/8¿ bd eclipse needles.One of our staff had a needle stick injury when activating the safety shield.The safety shield went sideways when pushed and broke off causing the nurse¿s thumb to scrape across the used needle.Defective product was not retained.
Additional Manufacturer Narrative
H.6.Investigation: one representative sample was received for investigation.The one representative sample was subjected to visual inspection.There were no deformation/damage observed on the eclipse hub and safety shield.No breakage observed on the safety lock pin.The representative sample was subjected to the eclipse safety shield inspection to check for hub hook breakage or safety shield fall off / break off.The sample passed the inspection activation / locking force :the representative sample was activated per test method procedure, it377.The activation force results met the specification requirements unable to confirm the customer experience as sample passed the inspection.A device history record review found no non-conformances associated with this issue during production of this batch.
Event or Problem Description
It has been reported that the syringe 3ml ll w/ndl eclipse 25x5/8 rb has been found experiencing safety mechanism failure during use.The following has been provided by the initial reporter: it was reported that the health care provider received a needle stick injury after the safety shield broke off.Verbatim: issue with 3ml 25g 5/8¿ bd eclipse needles.One of our staff had a needle stick injury when activating the safety shield.The safety shield went sideways when pushed and broke off causing the nurse¿s thumb to scrape across the used needle.Defective product was not retained.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9146696
• Report Number: 8041187-2019-00782
• Device Sequence Number: 2950785
• Product Code: FMI
• UDI-Device Identifier: 30382903057819
• UDI-Public: 30382903057819
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2019

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 305781
• Device Lot Number: 7326076
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/09/2019
• 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