• 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) PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC 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) PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383746
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 12/24/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the pegasus pnk 20gax1. 16in prn-capy non-pvc leaked blood at the adapter septum during use. The following information was provided by the initial reporter, translated from (b)(6) to english: after the infusion for the patient, practice nurses were not accompanied by the teacher to use prefilled syringe for the venipuncture care, about 15 minutes later after the operation, the families found that there was blood on his sleeve and bedding bag when patient turned over , so they hastened to call the on duty nurse, nurse checked the heparin cap of venous indwelling needle and found it fall off, preliminary assessment from the needle about 50 ml blood oozes out. So she immediately reported to the head nurse and contact the manufacturer's sales staff.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC
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
8015296192
MDR Report Key11206214
MDR Text Key228362782
Report Number3006948883-2021-00147
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 foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383746
Device Lot Number0019720
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 Received02/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-