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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¿ SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383745
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 1033650. 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. Investigation conclusion: the complaint gauge is 20g, assembly at manual line at (b)(4), lot quantity is (b)(4); reviewed the in process test and outgoing test report for this lot product, and all test results met the product specifications, no abnormality for it. Reviewed the assembly record, there no nonconformities, deviations or rework activities for this lot product were found. 45psi leakage test for the retain sample, no found leakage issue. Cannot identify the root cause of this complaint and will keep monitoring and tracking this defect complaint.
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system experienced leakage at diaphragm. The following information was provided by the initial reporter: due to the preoperative fluid rehydration treatment, the patient was treated with a closed intravenous indwelling needle of the type of needle puncture prevention on (b)(6) 2021. When the patient was used for intravenous fluid rehydration, the prn was replaced because of fluid leakage from the crack at the interface of the prn.
 
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Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceINTERVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
no.1 liangpu street
suzhou industrial park
suzhou 21512 6
CH 215126
MDR Report Key12490217
MDR Text Key280601213
Report Number3014704491-2021-00144
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
PENDING
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383745
Device Lot Number1033650
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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