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U.S. Department of Health and Human Services

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

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BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383712
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Fever (1858); Test Result (2695)
Event Date 03/14/2016
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. A sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a (b)(6) male patient was hospitalized for appendicitis, pneumonia, and benign prostatic hyperplasia. A bd pegasus safety closed iv catheter system was placed in the patient. Before surgery but after an infusion (the iv catheter placement time is not clear), the patient developed a high fever. Blood cultures were collected from the patient, tested positive, and the patient was treated with antibiotics. Of note, it was also reported that the hospital where the incident occurred conducted an investigation and confirmed that the iv catheter reported was not the cause of the reported fever.
 
Manufacturer Narrative
One unused and sealed sample was returned for evaluation. A visual/microscopic inspection revealed no irregularities and an endotoxin inspection met requirements (20 eu/device). A review of the device history record, incoming/outgoing inspection, packaging, and sterility record revealed no irregularities during the manufacture and sterilization of the reported lot # 5169315. Conclusion: an absolute root cause for this incident cannot be determined. Additionally, our quality engineer notes that the incident is not related to the manufacturing process of the device.
 
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Brand NameBD 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
8015652845
MDR Report Key5536677
MDR Text Key41522161
Report Number3006948883-2016-00013
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Catalogue Number383712
Device Lot Number5169315
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2015
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: 03/30/2016 Patient Sequence Number: 1
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