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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515111
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2021
Event Type  malfunction  
Event Description
It was reported that the bd phaseal¿ protector p50j experienced coring in the fluid path.The following information was provided by the initial reporter: this is a report about coring.During preparation of etoposide, small pieces were found in the syringe.
 
Manufacturer Narrative
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: d10: device available for eval yes.D10: returned to manufacturer on: 30-mar-2022.H6: investigation summary: n35j injector andp50j protector received for investigation.Upon visual inspection, no defect was found in the membrane, nor in the injector cannula.No damage observed in the protector.Foreign matter particles were observed inside the syringe that was connected to the injector.Fourier transform infrared spectroscopy was performed to identify the foreign matter.The foreign substance was composed of butyl rubber and silicic acid compounds, usually coming from the rubber stopper of the syringe and also from the phaseal membrane (talcum powder).A device history review was performed for reported lot 2104702, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.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, or if an incorrect stopper is used as in this case.The product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification and that there is no damage to the product.Based on the quality team's investigation, possible root cause is associated with the incorrect use of the rubber stopper corresponding to the cannula type of the protector.
 
Event Description
It was reported that the bd phaseal¿ protector p50j experienced coring in the fluid path.The following information was provided by the initial reporter: this is a report about coring.During preparation of etoposide, small pieces were found in the syringe.
 
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Brand Name
BD PHASEAL¿ PROTECTOR P50J
Type of Device
INTRAVASCULAR ADMINISTRATION SET
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 Key13064144
MDR Text Key285478533
Report Number3003152976-2021-00856
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 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515111
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
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
MATL# 515008, LOT# 2104702 INJECTOR LUER LOCK N35J
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