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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEGASUS BL 22GA X 1.00IN PRN-CAP Y CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) PEGASUS BL 22GA X 1.00IN PRN-CAP Y CATHETER Back to Search Results
Catalog Number 383732
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that pegasus bl 22ga x 1. 00in prn-cap y tubing clamp was loose. This occurred on 5 occasions. The following information was provided by the initial reporter: in the emergency department, when after injection, the blood is returned to the prn after the pinch clamp is closed.
 
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Brand NamePEGASUS BL 22GA X 1.00IN PRN-CAP Y
Type of DeviceCATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key12563169
MDR Text Key274561495
Report Number8041187-2021-00882
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
PENDING
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383732
Device Lot Number0361907
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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