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

Catalog Number 515304

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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¿ y-site connector c80 had a defective fitting.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that the bd phaseal¿ y-site connector c80 had a defective fitting.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, 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: 1 sample has been received.It was sent to subcontractor for evaluation.As the lot number is unknown for this incident, a complaint history check cannot be performed.Inspections and tests in manufacturing area: this product is not assembled or packaged in bd san agustin plant.The process performed on our plant is the sealing of the membrane on the connector.Then, this piece is sent to a subcontractor (carefusion-it) where the set assembly and packaging is carried out according to buy specification sb1746.After the set assembly and packaging at carefusion-it, some samples are sent to san agustin plant.Visual inspection is performed to verify the quality of the product according to fr-177 current version.These are the inspections performed during manufacturing process for connector: 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.-according to ph-303 it is 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 according to pc-226 (current version).Investigation conclusion: the root cause cannot be established.

• Brand Name: BD PHASEAL¿ Y-SITE CONNECTOR C80
• 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: 7700646
• MDR Text Key: 114708381
• Report Number: 3003152976-2018-00299
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905153045
• UDI-Public: 30382905153045
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/04/2018

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
• Device Operator: Other
• Device Catalogue Number: 515304
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/27/2018
• Supplement Dates FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other