MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ PHASEAL; INTRAVENOUS LINE/SYRINGE LUER CONNECTOR

Catalog Number	515001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ phaseal had foreign matter inside.
Additional Manufacturer Narrative
Investigation summary: five picture samples were received for evaluation by our quality engineer.A device history record review was performed on the provided lot number (1806102).The review did not reveal any quality issues during the production process that could have contributed to coring.Investigation conclusion: visual inspection of the pictures revealed the presence of small particles.As the particles appeared grey in color, it is possible that they derived from the rubber stopper.Through the picture samples, an evaluation of the protector needle is not possible.Root cause description: coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Based on the investigation results, a definite cause for this incident could not be determined.Rationale: use of the m12 assembly fixture is recommended to reduce coring tendency and ensure proper connection of the device.A corrective action and preventive action plan has been initiated to further investigate this issue.Complaints received for this device and defect will be closely monitored by our quality team.
Event or Problem Description
It was reported that bd¿ phaseal had foreign matter inside.

• Brand Name: BD¿ PHASEAL
• Common Device Name: INTRAVENOUS LINE/SYRINGE LUER CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8210619
• Report Number: 3003152976-2018-00576
• Device Sequence Number: 1900693
• Product Code: ONB
• UDI-Device Identifier: 30382905150013
• UDI-Public: 30382905150013
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

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: 11/30/2020
• Device Catalogue Number: 515001
• Device Lot Number: 1806102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/09/2019
• 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