MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INFUSION ADAPTER C100; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515306

Device Problems Chemical Spillage (2894); Device-Device Incompatibility (2919)

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

Event Date 05/25/2018

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¿ infusion adapter c100 connection between the baxter non-pvc saline bag and the bd phaseal connection adapter is involved in an incident with a chemo drug spill.There seems to be an incompatibility between the two products.It is extremely difficult to spike the baxter bag with the phaseal adaptor.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: one picture was provided: the infusion bag, the infusion adaptor and the lot are shown.Visual inspection of the sinfusion adaptor shows no defects.One retained sample was tested.Visual inspection shows no defects.No issues were found during the connection to the bag.No leak was found.No non-conformances were found during dhr review.Inspections in manufacturing area: all components of connector c100, except the membrane, are molded in nolato supplier.After molding, the components are assembled in (b)(4) plant.During assembly process, the operator performs visual inspection of the membrane, spike port, housing and cap to verify that product is free of damages (procedure ph-304, ph-081).The operator takes 24 samples for each 1.000 units and verified the welding of the membrane, correct assembly and quality of the components.During the packaging process of phaseal product, visual inspection of the product is performed by the operator according to ph-009 and ph-307.Eight samples are taken for visual inspections (2 strips) to verify the quality of the blisters.On the other hand, 100% visual inspection is performed for all phaseal product by the operator before place the product in the unit case.During the load of product in the unit cases, the operator checks the correct quality of the product (free of damages, f.M).In case of faulty product, it is sent to scrap.In case of packaging defects, samples are picked up and packaged again.Leakage test is performed in all lots according to (b)(4).Investigation conclusion: no defects were found in the retained sample.No non-conformances were found during dhr review.

• Brand Name: BD PHASEAL¿ INFUSION ADAPTER C100
• 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: 7611820
• MDR Text Key: 112287558
• Report Number: 3003152976-2018-00235
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905153068
• UDI-Public: 00382905153068
• 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: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 515306
• Device Lot Number: 1702105
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other