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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS BL 22GA X 0.75IN PRN NON-PVC INTRAVASCULAR ADMINISTRATION SET

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BD (SUZHOU) PEGASUS BL 22GA X 0.75IN PRN NON-PVC INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 383725
Device Problem Difficult or Delayed Activation (2577)
Patient Problem Blood Loss (2597)
Event Date 09/26/2019
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.
 
Event Description
It was reported that leakage occurred during use with a pegasus bl 22ga x 0. 75in prn non-pvc. The following information was provided by the initial reporter, "one 22ga pegasus was noticed that catheter detached from the catheter adapter and result in blood leakage during penetration around 13:50 p. M. Of (b)(6) 2019. Qty of leaked blood waiting for the confirmation from sales rep. One 22ga pegasus was noticed that needle disengagement difficult around 15:11 p. M. Of (b)(6) 2019. One 22ga pegasus was noticed that needle disengagement difficult around 16:10 p. M. Of (b)(6) 2019". 3 occurrences were reported.
 
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Brand NamePEGASUS BL 22GA X 0.75IN PRN NON-PVC
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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
8015652341
MDR Report Key9188512
MDR Text Key179487244
Report Number3006948883-2019-00863
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,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/26/2022
Device Catalogue Number383725
Device Lot Number9050942
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 Received09/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2019
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: 10/14/2019 Patient Sequence Number: 1
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