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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35J; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515008
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Event Description
It was reported while using bd phaseal¿ injector luer lock n35j a liquid didn't flow smoothly.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about a flow issue.The injector (n35) was connected to the connector (c35j) but fluid didn't flow.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported while using bd phaseal¿ injector luer lock n35j a liquid didn't flow smoothly.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about a flow issue.The injector (n35) was connected to the connector (c35j) but fluid didn't flow.
 
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.H6: investigation summary: one injector and one connector was provided to our quality team for investigation.Upon visual inspection of the products, no damage or other defects were observed.Functional testing was performed, in all cases liquid could flow between the injector and connector, no resistance was identified, and no evidence of an obstruction was found.A device history review was performed for injector lot 2107014, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Four retained samples of the same lot were used for additional evaluation.The samples were functionally tested and, in all cases, flow was observed and the product functioned as intended.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.Testing results for lot 2107014, along with the retained samples were reviewed, no defects were observed, and product met required specifications.Based on our investigation and sample evaluation, we cannot identify a root cause related to our process at this time.H3 other text : see h10.
 
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Brand Name
BD PHASEAL¿ INJECTOR LUER LOCK N35J
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 Key13875835
MDR Text Key288212328
Report Number3003152976-2022-00118
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 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2023
Device Catalogue Number515008
Device Lot Number2107014
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/09/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received07/06/2022
Supplement Dates FDA Received08/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2021
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
515204BD PHASEAL ¿ CONNECTOR LUER LOCK C35J
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