MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ Y-SITE CONNECTOR C80; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515304
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 the bd phaseal¿ y-site connector c80 had cracked connection.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that the bd phaseal¿ y-site connector c80 had cracked connection.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: one sample unit was received for evaluation by our quality engineer team.For the y-site connector product, bd performs the sealing of the membrane on the connector component.After the sealing process is completed, the product is sent to a subcontractor where product assembly and packaging is performed.The sample received was sent to the subcontractor location for further investigation.A hairline fracture on the female luer was identified through visual inspection of the sample.Through functionality testing, fluid was observed to leak from the crack within the luer component.The type of crack identified on the returned sample can potentially be caused or contributed to by a combination of different factors, including over-torque of the component during connection with the male luer, use of a male luer that is not compliant with standards, or prolonged use of substances that are aggressive to plastics.A definite cause could not be determined for this incident.As the lot number is unknown for this incident, a complaint history check cannot be performed.During molding process: visual inspections for connectors are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc).Critical to quality dimensions of all connector components are measured to check if the dimensions are within tolerance.Luer cone and luer thread diameter are checked every 8 hours and at the beginning of the lot and after a machine stop with a go / no go gauge.Tip luer cone diameter is verified at the beginning of the lot and after a machine stop with a caliber.Checked the correct welding and position of the membrane, the absence of cracks and dirt.Finally, leakage test is performed in the quality lab to ensure the quality and functionality of the membrane.Subcontractor investigation: a visual inspection of the sample identified a hairline crack on the female luer; functional testing confirmed the customer's experience as fluid was observed to leak from the crack.A definitive root cause for the cracked female luer component could not be determined in this instance.The type of crack identified on the returned sample can potentially be caused or contributed to by a combination of different factors, including over-torque of the component during connection with the male luer, use of a male luer that is not complaint to is standards, or prolonged use of substance that are aggressive to plastics.No lot number was provided to aid the investigation into this issue, therefore it is not possible to perform a review of the production records in order to identify any possible in process testing failures or quality deviations which may have caused or contributed to a report of this nature.At this time, further action has not been determined necessary.Final assembly and packaging for this product is in the process of being transferred to the bd facility from the subcontractor.

• Brand Name: BD PHASEAL¿ Y-SITE CONNECTOR C80
• 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: 7700717
• Report Number: 3003152976-2018-00300
• Device Sequence Number: 11456009
• Product Code: ONB
• UDI-Device Identifier: 30382905153045
• UDI-Public: 30382905153045
• 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,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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: Other
• Device Catalogue Number: 515304
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 10/12/2018
• 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