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	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 it was difficult to disengage the injector on a bd phaseal¿connector this caused the needle to remain exposed.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Dhr: n/a - no lot.Inspections and tests: 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).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).If the injector safety sleeve is broken, the needle will become exposed.When engaging/disengaging the injector it is important to grip only the white components; do not tough the blue safety sleeve.If the grips of the safety sleeve are dislocated, the injector will become activated and the needle will become exposed.The injector must be removed by pulling straight back to avoid damage to the grips.If the injector has been forcefully engaged, the grips may also become damaged.As a sample was unavailable for this incident, an exact cause could not be determined.Complaints received for this device and defect will continue to be monitored by our quality team for emerging trends.
Event or Problem Description
It was reported that it was difficult to disengage the injector on a bd phaseal¿connector this caused the needle to remain exposed.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: 7996360
• Report Number: 3003152976-2018-00461
• Device Sequence Number: 1381443
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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: 515202
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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