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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383912
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2022
Event Type  malfunction  
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 that the bd pegasus yel 24ga x 0.75in prn-cap y experienced difficult safety needle disengagement.The following information was provided by the initial reporter: the patient was in the state of tracheotomy, continuously connected to a ventilator to assist breathing, and continued intravenous infusion.The nurse in charge of the patient punctured the patient with a venous indwelling needle and used a closed puncture-proof venous indwelling needle for puncture.After the venipuncture was successful, when the needle core was withdrawn, the needle wing in the right hand should be pulled out with a relatively large amount of force.Out of the needle core, the puncture failed due to a force.The indwelling needle was replaced and the puncture was finally successful with the cooperation of two nurses.
 
Event Description
It was reported that the bd pegasus yel 24ga x 0.75in prn-cap y experienced difficult safety needle disengagement.The following information was provided by the initial reporter: the patient was in the state of tracheotomy, continuously connected to a ventilator to assist breathing, and continued intravenous infusion.The nurse in charge of the patient punctured the patient with a venous indwelling needle and used a closed puncture-proof venous indwelling needle for puncture.After the venipuncture was successful, when the needle core was withdrawn, the needle wing in the right hand should be pulled out with a relatively large amount of force.Out of the needle core, the puncture failed due to a force.The indwelling needle was replaced and the puncture was finally successful with the cooperation of two nurses.
 
Manufacturer Narrative
H.6.Investigation summary: in response to the event reported, a device history review was conducted for lot number 2098655.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.
 
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Brand Name
BD PEGASUS YEL 24GA X 0.75IN PRN-CAP Y
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH  215126
Manufacturer (Section G)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH   215126
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15936040
MDR Text Key308086070
Report Number3014704491-2022-00645
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
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 12/11/2022
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 Catalogue Number383912
Device Lot Number2098655
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/14/2022
Initial Date FDA Received12/07/2022
Supplement Dates Manufacturer Received12/11/2022
Supplement Dates FDA Received12/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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