• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD (SUZHOU) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383911
Device Problem Insufficient Information (3190)
Patient Problems Purulent Discharge (1812); Erythema (1840); Phlebitis (2004); Swelling (2091)
Event Date 05/13/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). 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 patient developed phlebitis in conjunction with the use of a bd pegasus safety closed iv catheter system. There was redness, swelling, and purulence at the iv insertion site and the patient was treated with mupirocin ointment.
 
Manufacturer Narrative
One used sample without unit packaging was returned for evaluation. A visual inspection revealed no abnormalities. A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6018475. A review of the sterility records revealed no abnormality during eo sterilization and that the eo residual and sterility test met requirements. Conclusion: an absolute root cause for this incident cannot be determined. There are multiple factors that can contribute to phlebitis and no abnormalities were discovered during the investigation of the reported device.
 
Manufacturer Narrative
Additional information: the device expiration date was omitted from the initial mdr. Device expiration date: 01/31/2019.
 
Manufacturer Narrative
Correction: the patient identifier was incorrectly entered on the second supplemental mdr as (b)(6). The correct patient identifier is: (b)(6).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key5690222
MDR Text Key46256635
Report Number3006948883-2016-00017
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,Followup,Followup
Report Date 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number383911
Device Lot Number6018475
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 Received05/13/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2016
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: 05/31/2016 Patient Sequence Number: 1
-
-