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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P50J
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BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P50J Back to Search Results
Catalog Number 515111
Device Problem No Pressure (2994)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that coring was observed while using bd phaseal¿ protector p50j.The following information was provided by the initial reporter: hcp drew trastuzumab after injecting and dissolving solution in 3 vials.S/he found coring when drawing the 3rd vial.
 
Event Description
It was reported that coring was observed while using bd phaseal¿ protector p50j.The following information was provided by the initial reporter: hcp drew trastuzumab after injecting and dissolving solution in 3 vials.S/he found coring when drawing the 3rd vial.
 
Manufacturer Narrative
H.6.Investigation: one injector attached to a syringe, protector and vial, along with two additional protectors attached to a vial were returned to our quality team for investigation.The product was visually inspected, no defects or damage was observed on the protectors, the protectors fit securely to the vial, and the needle on the protector penetrated the vial stopper properly.Through visual inspection, a foreign particle was observed inside the syringe.Characterization testing was performed and identified the particle was likely fragments of the rubber stopper from the vial.Fragmentation testing is performed during manufacturing to identify any particles generated by the injector after ten activations.A device history review was performed for reported lot 1901129, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.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 information we are not able to identify a definitive root cause at this time.
 
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Brand Name
BD PHASEAL PROTECTOR P50J
Type of Device
PROTECTOR
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key10106166
MDR Text Key208191778
Report Number3003152976-2020-00231
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2023
Device Catalogue Number515111
Device Lot Number1901129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2020
Date Manufacturer Received05/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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