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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 WITH Q-SYTE¿; INTRAVASCULAR CATHETER
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BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WITH Q-SYTE¿; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383718
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2022
Event Type  malfunction  
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system with q-syte¿ experienced damaged packaging where the sterility was compromised.The following information was provided by the initial reporter: packaging was found to be damaged during the pre-infusion check, and was replaced immediately.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary a device history review was conducted for lot number 1321729.There were no nonconformities, deviations or rework activities in the process of this batch of products.No samples or pictures returned.Inspected the appearance of retain sample, no package damaged defect found.The history of customer complaints for the same batch of products has been reviewed, and no complaints of the same defects have been found.The root cause of the complaint defect cannot be confirmed.H3 other text : see h10.
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system with q-syte¿ experienced damaged packaging where the sterility was compromised.The following information was provided by the initial reporter: packaging was found to be damaged during the pre-infusion check, and was replaced immediately.
 
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Brand Name
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WITH Q-SYTE¿
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 Key15992114
MDR Text Key306519665
Report Number3014704491-2022-00664
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 01/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383718
Device Lot Number1321729
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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