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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) UNSPECIFIED BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER

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BD (SUZHOU) UNSPECIFIED BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Skin Inflammation (2443); Alteration In Body Temperature (2682)
Event Date 03/28/2020
Event Type  Injury  
Manufacturer Narrative
Medical device expiration date: unknown. Initial reporter phone #: unknown. Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that phlebitis occurred after use with an unspecified bd pegasus¿ safety closed iv catheter system. The following information was provided by the initial reporter, translated from (b)(6) to english: (b)(6) years old, was admitted to the hospital for lung cancer on (b)(6) 2020. At 10:30 on (b)(6) a needle indwelling catheter was placed on the inner forearm. On (b)(6) the doctor found that the patient was indwelling a needle puncture redness and pain in the blood vessel, immediately remove the indwelling needle, the patient's skin temperature is slightly higher and slightly swollen, the doctor immediately gave warm water compress as directed by the doctor, and if necessary, injected with magnesium sulfate injection, the patient's skin returned to normal the next day.
 
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Brand NameUNSPECIFIED BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer (Section G)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9981523
MDR Text Key188672346
Report Number3006948883-2020-00144
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/21/2020 Patient Sequence Number: 1
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