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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INJECTOR LUER LOCK N35J
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BECTON DICKINSON, S.A. INJECTOR LUER LOCK N35J Back to Search Results
Catalog Number 515008
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that injector luer lock n35j had flow issues.The following information was provided by the initial reporter: during preparation, the hcp attempted to aspirate saline with the injector but could not aspirate it.When using the other new injector, the hcp could do the operation.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-06-18.H6: investigation summary one injector sample was provided to our quality team for investigation.The product was visually inspected with no defects observed.The sample was functionally tested, resistance was noted when attempting to aspirate liquid from the vial.The injector was further evaluated and found the needle of the injector was partially clogged by a polypropylene particle.A device history review was performed for suspected lots 2007012 and 2007002, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue for lot, however, a maintenance order was completed during product of lot 2007002 related to stops in the stations that insert the needle into the protector housing.Adjustments were made in these stations and the issue was solved.Four retained samples of lot lots 2007012 and four samples of lot 2007002 were used for additional evaluation.Functional testing was performed, connecting protector samples to a vial, injector, and syringe per the instructions for use provided with the product.In all cases the liquid was able to be drawn from the vial, the product functioned as intended, and no flow issues or resistance was observed.All retained samples were disassembled for further evaluation, no clog was identified in any of the cannulas.Product undergoes visual and functional inspections prior to release, including verification the product is not damaged, flow rate, and all critical dimensions meet specifications.Upon reviewing the results for the suspected lots, no issues were identified during testing and the product met the required criteria for release.While we cannot identify a direct issue, it was determined this incident is related to the maintenance order completed during manufacturing which may have lead to the to improper positioning of the cannula when inserted into the needle housing and can result in the polypropylene becoming pulled into the cannula, creating an occlusion.Manufacturing personnel have been notified of this incident to increase awareness.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
 
Event Description
It was reported that injector luer lock n35j had flow issues.The following information was provided by the initial reporter: during preparation, the hcp attempted to aspirate saline with the injector but could not aspirate it.When using the other new injector, the hcp could do the operation.
 
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Brand Name
INJECTOR LUER LOCK N35J
Type of Device
INJECTOR
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key12104189
MDR Text Key263542119
Report Number3003152976-2021-00358
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 08/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
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
Date Returned to Manufacturer06/18/2021
Date Manufacturer Received08/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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