• 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 383711
Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2017
Event Type  Injury  
Manufacturer Narrative
Results: bd received one sample from the customer in support of this complaint. The failure mode was observed in the sample provided by the customer, and no additional abnormalities in the incoming material, assembly process or packaging process were observed in the batch record. The indwelling needle was being used for 4 days (b)(6) it was fine for the first 3 and failed on the fourth. Because the unit behaved normally for the first three days it was determined to be within specification. (b)(4) cannot finalize the root cause of the plant as a result. A review of the device history record revealed no irregularities during the manufacture of the reported lot number. Conclusion: in conclusion, based on the current investigation, no abnormality was found at the beginning of using. (b)(4) plant can't finalize the root cause for this kind of failure.
 
Manufacturer Narrative
Medical device lot #: 7083015, medical device expiration date: 3/31/2020, device manufacture date: 3/24/2017. Medical device lot #: 7110497, medical device expiration date: 4/30/2020, device manufacture date: 4/20/2017. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that on day two of using the bd pegasus¿ safety closed iv catheter system it malfunctioned as the catheter was found with the ¿indwelling portion missing from the root of the tube. ¿ medical intervention was needed and an x- ray was performed. It is unknown what further medical intervention was given.
 
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 Key7144115
MDR Text Key116936397
Report Number3006948883-2017-00188
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 01/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383711
Device Lot NumberSEE H.10.
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 Received12/04/2017
Was Device Evaluated by Manufacturer? Yes
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: 12/22/2017 Patient Sequence Number: 1
-
-