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

Catalog Number	515202
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture 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.
Event or Problem Description
It was reported that the connector of a bd phaseal¿connector was not opening the iv tubing valve.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: as no pictures/samples are available the defect cannot be confirmed.As the lot is unknown, the device history record cannot be checked and due to the same reason, retained samples cannot be tested.In order to guarantee the properly function of phaseal devices, instructions explained in the ifu must be carefully followed.The root cause cannot be established upon information received.Leakage-other the customer complaints about leak and flow issues with c45 connector.No pictures or samples are available.There is no information about the lot number.Inspections and tests in manufacturing area: these are the inspections performed during manufacturing process for connector c45: during molding process: visual inspections for connectors are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc) according to ph-300 (current version).Critical to quality dimensions of all connector components are measured to check if the dimensions are within tolerance (ph-300).Luer cone and luer thread diameter are checked every 8 hours and at the beginning of the lot and after a machine stop.Go / no go gauge.Tip luer cone diameter is verified at the beginning of the lot and after a machine stop with a caliber.Assembly process: according to ph-303 it is checked the correct welding and position of the membrane, the absence of dirt and the well assembly of the cap.The correct welding of the membrane is doing according to pc-234 (current version).Finally, leakage test is performed in the quality lab to ensure the quality and functionality of the membrane according to pc-226 (current version).Conclusion: as no pictures/samples are available the defect cannot be confirmed.As the lot is unknown, the device history record cannot be checked and due to the same reason, retained samples cannot be tested.

• 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: 7328379
• Report Number: 3003152976-2018-00105
• Device Sequence Number: 13488947
• Product Code: ONB
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: Nurse
• Device Catalogue Number: 515202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 03/15/2018
• 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