MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ CONNECTOR LUER LOCK (C35); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515200
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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1905108.Medical device expiration date: 2023-04-30.Device manufacture date: 2019-05-22.Medical device lot #: 1905112.Medical device expiration date: 2023-04-30.Device manufacture date: 2019-05-29.Medical device lot #: 1906107.Medical device expiration date: 2023-05-31.Device manufacture date: 2019-06-24.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the bd phaseal¿ connector luer lock (c35) there is an issue with the connection between the connector and injector.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: 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: injector with cap: 1904101, 1906110.Connector: 1905108, 1905112, 1906107.
Additional Manufacturer Narrative
Investigation: a total of 39 connector samples 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 connectors and a sample injector from lot 1906110 as well as lot 1904101.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 1905108, 1905112, and 1906107, 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 was reported that during use of the bd phaseal¿ connector luer lock (c35) there is an issue with the connection between the connector and injector.Foreign complaint the following information was provided by the initial reporter, translated from dutch to english: 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: injector with cap: 1904101, 1906110.Connector: 1905108, 1905112, 1906107.

• Brand Name: BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
• 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: 9104841
• Report Number: 3003152976-2019-00652
• Device Sequence Number: 11359864
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K123213
• 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 Catalogue Number: 515200
• Device Lot Number: SEE H.10
• 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