MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Model Number	515004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of injector luer lock n35c experienced luer breakage -leakage during use.The following information was provided by the initial reporter: when they are using phaseal the customer tried to get the injector from the connector but broke the injector and got the need visible.The nurse also got a needle stick injury.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1905109, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Functional testing was performed, connecting the injector to a sample syringe, protector and vial according to the instructions for use.Liquid was withdrawn from the vial and the injector was then connected to a connector and disconnected, repeating this process three times.In all cases the product functioned properly, and no issues were observed.It is important to hold onto the white components of the injector when engaging/disengaging; and not grip the blue safety sleeve.If not done properly, the safety sleeve may become disengaged which can result in the needle becoming exposed.To avoid damage to the safety sleeve grips, it cannot be forcefully engaged.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that an unspecified number of injector luer lock n35c experienced luer breakage -leakage during use.The following information was provided by the initial reporter: when they are using phaseal the customer tried to get the injector from the connector but broke the injector and got the need visible.The nurse also got a needle stick injury.

• Brand Name: INJECTOR LUER LOCK N35C
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9451766
• Report Number: 3003152976-2019-00848
• Device Sequence Number: 17005553
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• 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): 02/18/2020

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 Expiration Date: 10/31/2021
• Device Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: 1905109
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/18/2020
• 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