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

Model Number	515200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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.Device manufacture date: unknown.
Event or Problem Description
Material no: 515200, batch no: unknown.It was reported that during use of the bd phaseal¿ connector luer lock c35 leakage occurred between the injector and the connector.Bd was initially made aware of leakage issue reported on (b)(4).It was not until (b)(6) 2019 that the customer confirmed that there was leakage between the injector and connector.The following information was provided by the initial reporter: event description per sfdc pir states: information related to the leakage with chemo phaseal connector that i discussed with you over the phone.There have been a few leakage incidents and some nurses have been using additional tape to secure the connector and iv line.
Event or Problem Description
Material no: 515200 batch no: unknown.It was reported that during use of the bd phaseal¿ connector luer lock c35 leakage occurred between the injector and the connector.Bd was initially made aware of leakage issue reported on (b)(4).It was not until (b)(6) 2019 that the customer confirmed that there was leakage between the injector and connector.The following information was provided by the initial reporter: event description per sfdc pir states: information related to the leakage with chemo phaseal connector that i discussed with you over the phone.There have been a few leakage incidents and some nurses have been using additional tape to secure the connector and iv line.
Additional Manufacturer Narrative
H.6.Investigation summary: one photo was provided to our quality team for investigation.While the photo displayed the location of the leak, there was no evidence of a leakage that could be observed from that photo.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.As lot information for this incident was not available, a device history review could not be performed.Based on the available information we are not able to identify a root cause at this time.The performance of the sealing membrane is reduced after multiple perforations and extended activation time.It is important to follow the instructions for use when using phaseal devices to ensure the product functions properly.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

• 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: 9484599
• Report Number: 3003152976-2019-00864
• Device Sequence Number: 14145405
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: Health Professional
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/17/2020
• 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