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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. L CONNECTOR C90J; PHASEAL CONNECTOR
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BECTON DICKINSON, S.A. L CONNECTOR C90J; PHASEAL CONNECTOR Back to Search Results
Catalog Number 515309
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 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the l connector c90j experienced foreign matter/coring observed in vial or fluid path.The following information was provided by the initial reporter: according to the customer's report, the hcp draw saline from a saline bag into n35j with a syringe and then discovered a black fm.
 
Event Description
It was reported that the l connector c90j experienced foreign matter/coring observed in vial or fluid path.The following information was provided by the initial reporter: according to the customer's report, the hcp draw saline from a saline bag into n35j with a syringe and then discovered a black fm.
 
Manufacturer Narrative
The following fields were updated due to additional information: concomitant medical products: device available for eval yes.Returned to manufacturer on: 2021-03-19.H6: investigation summary: one infusion bag connected to a c90 connector 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 membranes of either device, the spike of the connector, or needle of the injector.During our evaluation, a black foreign particle was observed inside the syringe.Given the small size of the particle, characterization testing was not able to identify the composition.Qualitive testing of the elements using x-ray was performed and found the particle consisted mainly of iron, a material that is not verified to be in the phaseal components.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 sample investigation, it does not appear as though the particle originated from the phaseal devices; therefore we cannot identify a root cause at this time.H3 other text : see h10.
 
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Brand Name
L CONNECTOR C90J
Type of Device
PHASEAL CONNECTOR
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key11345811
MDR Text Key268247382
Report Number3003152976-2021-00096
Device Sequence Number1
Product Code LHI
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 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515309
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Date Manufacturer Received04/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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