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

Catalog Number	515202
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.(b)(6).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 was reported that bd phaseal¿connector leaked vapors out of the device.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation: three injector samples, three connector samples, and three protector samples were received for evaluation by our quality engineer team.A device history record review was performed for the connector lot number, 1804104, and the review did not reveal any quality issues during the production process that could have contributed to this incident.Through visual inspection of the samples, no defects were observed.Leakage testing was performed for each sample and no signs of leakage were observed.The injectors and connectors were attached to an infusion bag and no signs of leakage were observed.The protectors were connected to vials they performed per specification with no signs of leakage.As no signs of leakage, including vapor leakage, were observed, a cause for the reported incident could not be determined.
Event or Problem Description
It was reported that bd phaseal¿connector leaked vapors out of the device.No serious injury or medical intervention was reported.

• Brand Name: BD PHASEAL¿CONNECTOR
• 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: 8180368
• Report Number: 3003152976-2018-00550
• Device Sequence Number: 13804366
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/20/2019

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: 03/31/2022
• Device Catalogue Number: 515202
• Device Lot Number: 1804104
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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