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	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd phaseal¿connector leaked.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: fifty-seven sample units belonging to lot number 1707001 were received for evaluation by our quality engineer.A device history record review was performed on the provided lot number and no quality issues were found during the production process that may have contributed to the reported incident.Investigation conclusion: visual inspection was performed on the returned samples and no defects were observed.Leakage testing was performed on twenty of the returned samples and no signs of leakage were found through the phaseal membrane.Five of the samples were connected to infusions sets and the connectors worked per specification with no signs of leakage.Root cause description: based on the investigation results, the reported incident could not be replicated and therefore, an exact cause for the reported incident could not be determined.Rationale: the performance of the sealing membrane is reduced after multiple perforations and extended activation time.It is recommended that no more than ten perforations are performed.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.

• 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: 8196497
• Report Number: 3003152976-2018-00563
• Device Sequence Number: 2125146
• Product Code: ONB
• UDI-Device Identifier: 30382905152024
• UDI-Public: 30382905152024
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/16/2019

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: 06/30/2021
• Device Catalogue Number: 515202
• Device Lot Number: 1707001
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/16/2019
• 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