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

Catalog Number	515004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 injector luer lock n35c has been found with the injector loose during use.The following has been provided by the initial reporter: once again we encounter problems with the connection between the connector and injector in the department with a delivered cytostatic syringe.This was 3 times the case for an intrathecal injection on pediatric oncology this week.It is difficult to determine which lot number was used.We have different lot numbers of injectors with cap and connectors in stock.
Additional Manufacturer Narrative
Investigation: ten samples of lot 1906110 and an additional ten samples of lot 1904101 were returned to our quality team for investigation.The product was visually inspected and no defects were identified.Functional testing was performed, engaging and disengaging the injectors and a sample connector from lot 1905108 as well as lot 1905112.In all cases the product functioned properly, and no issues were observed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.A device history review was performed for lots 1906110 and 1904101, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It has been reported that the injector luer lock n35c has been found with the injector loose during use.The following has been provided by the initial reporter: once again we encounter problems with the connection between the connector and injector in the department with a delivered cytostatic syringe.This was 3 times the case for an intrathecal injection on pediatric oncology this week.It is difficult to determine which lot number was used.We have different lot numbers of injectors with cap and connectors in stock.

• 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: 9106937
• Report Number: 3003152976-2019-00657
• Device Sequence Number: 1865136
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 11/20/2019

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: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 515004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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