MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PHASEAL¿ PROTECTOR; PHASEAL ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Defective Device (2588)

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

Event Date 10/30/2018

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the unspecified bd phaseal¿ protector had issues with stopper coring.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

As no physical sample, picture sample, product code, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Phaseal needles are designed to reduce the coring tendency.If coring comes from membrane: a) human error: performing multiple injections on the membrane could lead to fragmentation.B) 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.C) materials: needles.If coring comes from rubber stopper: d)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.E) 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.F) 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.In the description of the complaint, it is explained that the fragment/s found belong to the rubber stopper.Taking into account the lack of information it is no possible to confirm the root cause of the defect (bad quality of the rubber stopper, defect in the needle of the protector or in needle of other device attached, or misuse by the user).

Event Description

It was reported that the unspecified bd phaseal¿ protector had issues with stopper coring.There was no report of exposure, injury, or medical intervention.

• Brand Name: UNSPECIFIED BD PHASEAL¿ PROTECTOR
• Type of Device: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8078549
• MDR Text Key: 127568430
• Report Number: 2243072-2018-01642
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other