MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA PROTECTOR (P20-O); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515064

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.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.(b)(4).

Event Description

It was reported that coring occurred in the medication vial with use of the bd phaseal¿ optima protector (p20-o) and regular filter needle.The following information was provided by the initial reporter: "we have been experiencing coring with one of our medications lately, and have just been made aware of another pharmacy that is having coring with a different medication (also using a different cstd as well).We currently do not have a filter product that is compatible for use with the phaseal, so we have been improvising with our regular filter needles, somewhat defeating the purpose of the closed system for those orders." "the coring appears in the bottom right hand side of the vial.This drug comes in powder form with its own diluent.We withdraw from the vial using an 18g needle, then swap out the needle with a phaseal optima injector.At this step, no coring was seen.The vial and phaseal p20 protector were assembled manually, at which point the drug was diluted.After dilution, coring was observed in the vial.This is the only medication we have observed coring with so far.".

Event Description

It was reported that coring occurred in the medication vial with use of the bd phaseal¿ optima protector (p20-o) and regular filter needle.The following information was provided by the initial reporter: "we have been experiencing coring with one of our medications lately, and have just been made aware of another pharmacy that is having coring with a different medication (also using a different cstd as well).We currently do not have a filter product that is compatible for use with the phaseal, so we have been improvising with our regular filter needles, somewhat defeating the purpose of the closed system for those orders."."the coring appears in the bottom right hand side of the vial.This drug comes in powder form with its own diluent.We withdraw from the vial using an 18g needle, then swap out the needle with a phaseal optima injector.At this step, no coring was seen.The vial and phaseal p20 protector were assembled manually, at which point the drug was diluted.After dilution, coring was observed in the vial.This is the only medication we have observed coring with so far.".

Manufacturer Narrative

H.6.Investigation: one photo sample was provided to our quality team for investigation.Through visual inspection of the photo, a grey particle was observed on the bottom of the vial, however, without the physical sample we cannot properly identify the composition or origin of the particle that was observed.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.As a lot number was unavailable for this incident, a device history record review could not be completed.Based on the available we are not able to identify a definitive root cause at this time.

• Brand Name: BD PHASEAL OPTIMA PROTECTOR (P20-O)
• 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: 11088639
• MDR Text Key: 227976282
• Report Number: 3003152976-2020-00588
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: 00382905150647
• Combination Product (y/n): N
• PMA/PMN Number: K181221
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515064
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1