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

Catalog Number 515200

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd phaseal¿ connector luer-lock-connector c35 was assembled with spike needle by atom medical.The c35 was damaged before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: four pictures and the affected sample was received by our quality team for investigation.Upon visual inspection of the sample and pictures, it was verified that the c35 was damaged.The connector is broken in two sides.The membrane is not punctured, which confirms that it was not assembled with an injector.However, it seems that the connector was forced in any way and broken as a result.The breakage is not thought to be produced during manufacturing process.As the lot is unknown, retained samples and dhr cannot be reviewed.Customer complaints about the connector breakage.The connector is manufactured at bd san agustin plant but final device is assembled by atom medical.The pictures and sample received confirmed the claimed defect.It appears broken in two sides.Inspections and tests in manufacturing area: these are the inspections performed during manufacturing process for connector c35: 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 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.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).Investigation conclusion: the connector is broken in two sides.The membrane is not punctured, which confirms that it was not assembled with an injector.However, it seems that the connector was forced in any way and broken as a result.The breakage is not thought to be produced during manufacturing process.As the lot is unknown, retained samples and dhr cannot be reviewed.

• Brand Name: BD PHASEAL¿ CONNECTOR LUER-LOCK-CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7371534
• MDR Text Key: 103691452
• Report Number: 3003152976-2018-00112
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905152009
• UDI-Public: 00382905152009
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 03/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other