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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C45J
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BECTON DICKINSON, S.A. CONNECTOR LUER LOCK C45J Back to Search Results
Catalog Number 515206
Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2019
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 connector luer lock c45j had flow issues.The following information was provided by the initial reporter: connected with chemo safe infusion set, sure plug and connector luer lock c45.Hcp tried to give chemo from 515511-zat to the patient.However the infusion didn't flow.When pressed the infusion bag, it flowed a bit.Replaced by new connector luer lock c45 and it flowed.
 
Event Description
It was reported that connector luer lock c45j had flow issues.The following information was provided by the initial reporter: connected with chemo safe infusion set, sure plug and connector luer lock c45.Hcp tried to give chemo from 515511-zat to the patient.However the infusion didn't flow.When pressed the infusion bag, it flowed a bit.Replaced by new connector luer lock c45 and it flowed.
 
Manufacturer Narrative
H.6.Investigation: one sample was received by our quality team for investigation.Upon visual inspection of the sample received, no defects were noted; therefore, the failure could not be confirmed.Retained sample testing nor a device history record could be evaluated as the lot number is unknown.Based on the quality team's investigation, since no defects were found after the visual inspection of the returned sample ruling out the possibility of an incidence during the process or shipping and no design related potential causes were identified that could contribute to the flow failure mode that was reported, the root cause could not be established.H3 other text : see h.10.
 
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Brand Name
CONNECTOR LUER LOCK C45J
Type of Device
CONNECTOR
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key8683842
MDR Text Key147606794
Report Number3003152976-2019-00390
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
PMA/PMN Number
N/A
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 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number515206
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Initial Date Manufacturer Received 05/23/2019
Initial Date FDA Received06/10/2019
Supplement Dates Manufacturer Received05/23/2019
Supplement Dates FDA Received08/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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