MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C45; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515202
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1809105; medical device expiration date: 2022-08-31; device manufacture date: 2018-09-12; medical device lot #: 1711109; medical device expiration date: 2021-10-31; device manufacture date: 2017-11-17.
Event or Problem Description
It was reported that the connector luer lock c45 experienced leakage.The following information was provided by the initial reporter: material no: 515202, batch no: 1809105, 1711109.It was reported that during administration of velcade, 3-5 drops of the chemotherapy drug leaked from the needle/phaseal connection onto the patient.Event description medwatch report states, "nurse administering velcade subq using bd phaseal closed system drug transfer device, 3-5 drops of chemotherapy medication leaked from the needle-phaseal connection onto the patient.This is not the first time the phaseal has malfunctioned when administering a medication subcutaneously.Connector luer lock were used in this event, however, the event was replicated in the past with other lot numbers.Bd has been notified in the past of this issue.".
Additional Manufacturer Narrative
H.6.Investigation: no photos or physical samples that display the reported condition were provided for investigation.A device history review was performed for reported lots 1809105 and 1711109, no deviations or non-conformances related to this issue were identified during the manufacturing process.Retained samples from each lot were used for additional evaluation.Visual inspections did not reveal any defects and no leakages were observed.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 the connector luer lock c45 experienced leakage.The following information was provided by the initial reporter: material no: 515202 batch no: 1809105, 1711109.It was reported that during administration of velcade, 3-5 drops of the chemotherapy drug leaked from the needle/phaseal connection onto the patient.Event description per attached medwatch report states, "nurse administering velcade subq using bd phaseal closed system drug transfer device, 3-5 drops of chemotherapy medication leaked from the needle-phaseal connection onto the patient.This is not the first time the phaseal has malfunctioned when administering a medication subcutaneously.Connector luer lock were used in this event, however, the event was replicated in the past with other lot numbers.Bd has been notified in the past of this issue.".

• Brand Name: CONNECTOR LUER LOCK C45
• 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: 8501186
• Report Number: 3003152976-2019-00262
• Device Sequence Number: 1846131
• Product Code: FPA
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/21/2019

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: 515202
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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
• Patient Age: 42 YR