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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEGASUS BL 22GA X 0.75IN PRN-CAP Y CATHETER

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BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. PEGASUS BL 22GA X 0.75IN PRN-CAP Y CATHETER Back to Search Results
Catalog Number 383922
Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2019
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 has been reported that one pegasus bl 22ga x 0. 75in prn-cap y has been found with a broken needle during use. The following has been provided by the initial reporter: after completed penetration,it's noticed that needle tip broken after retract the needle core.
 
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Brand NamePEGASUS BL 22GA X 0.75IN PRN-CAP Y
Type of DeviceCATHETER
Manufacturer (Section D)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer (Section G)
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
9 rui pu road export zone b
suzhou
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9540655
MDR Text Key181442480
Report Number3006948883-2019-01160
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
PENDING
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 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/12/2021
Device Catalogue Number383922
Device Lot Number8325787
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 Received12/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/21/2018
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: 01/02/2020 Patient Sequence Number: 1
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