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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR; INTRAVASCULAR CATHETER
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BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 515008
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  malfunction  
Event Description
It was reported bd phaseal protector contained foreign matter.The following information was provided by the initial reporter: "during preparation of bevacizumab by using the protector attached to the vial, a floating matter was found in the vial.".
 
Manufacturer Narrative
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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 30-jun-2022.: investigation summary one protector attached to a vial along with one syringe connected to a injector were returned to our quality team for investigation.The product was visually inspected, no defects or damage observed on the protector, the protector fit securely to the vial, however it was noted to be attached at an incline and the stopper of the vial appeared to have been penetrated multiple times.During our evaluation, a foreign particle was observed.Characterization testing was performed and found the particles were mainly butyl rubber and silicic acid compounds, which is not consistent material from the rubber stopper of the vial nor our product membranes.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.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.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.It is important to ensure the vial is not expired as that can impact the quality of the rubber stopper.Based on the available we are not able to identify a definitive root cause at this time.
 
Event Description
It was reported bd phaseal protector contained foreign matter.The following information was provided by the initial reporter: "during preparation of bevacizumab by using the protector attached to the vial, a floating matter was found in the vial.".
 
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Brand Name
BD PHASEAL PROTECTOR
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14135361
MDR Text Key289445604
Report Number3003152976-2022-00146
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515008
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
515109 - PROTECTOR P14J
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