MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515105

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: phaseal needles are designed to reduce the coring tendency.If coring comes from membrane: human error: performing multiple injections on the membrane could lead to fragmentation.Machines: if membrane is excessively welded, consistency is higher and elasticity lower, and once it is pierced by the needle, it could provoke membrane fragmentation.Materials: needles.If coring comes from rubber stopper: materials: rubber stopper.Quality of rubber stopper will impact the occurrence of particles.The larger the percentage of inorganic filler in the rubber stopper, the more often cores and fragments will be produced.Capping conditions have shown to have significant effect on coring tendency.The type of crimping device used as well as the sealing force will have an influence on coring.Materials: needles.Design and dimensions of the needle influence the tendency for coring, especially regarding the production of larger cores, cut out from the rubber stopper by the needle edges.Phaseal needles are designed to reduce occurrence of coring.Misuse by the user: if the user makes a bad connection or turn the protector on the cap of the vial rather than insert it vertically, the cannula of the protector because of the rubbing with the stopper of the vial may cause detachment of particles from the cap of the vial.It is recommended to carefully follow the instructions explained in the ifu.For every manufactured lot the laboratory technician made the particles fragmentation test according to the it-1730 procedure.The test is carried out within a in a laminate flow hood.Staff has to wear a lab coat, cap and gloves.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.A review of the device history record could not be completed for the incident lot as no samples were provided.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode.Root cause description: coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.As several factors impact the coring tendency, a definite cause could not be determined for this incident.There were no changes in phaseal protectors recently.Use of the m12 assembly fixture is recommended to ensure proper connection of the protector to the vial.Rationale: complaints received for this device and defect will be closely monitored by our quality team and a corrective and preventive action plan has been initiated to prevent this defect from reoccurring.Prior to the investigation of this complaint a capa was open to assess coring tendency.

Event Description

It was reported that coring occurred with the bd phaseal¿ protector p50 during use.

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be performed as no lot information was provided.Based on the available information we were not able to fully investigate this issue therefore a root cause cannot be determined at this time.The complaint can't be confirmed.

Event Description

It was reported that coring occurred with the bd phaseal¿ protector p50 during use.

• Brand Name: BD PHASEAL¿ PROTECTOR P50
• 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: 8354206
• MDR Text Key: 136865756
• Report Number: 3003152976-2019-00165
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: 30382905151058
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other