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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM; SALINE, VASCULAR ACCESS FLUSH
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BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 383745
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system experienced leakage at the adapter septum.The following information was provided by the initial reporter: on (b)(6) 2020, the ct room nurse indwelling the patient with 20g straight pegasus in the middle of the elbow.After removing the needle , there was blood leakage at the end of the septum.The examination could be completed normally.
 
Event Description
It was reported that the bd pegasus¿ safety closed iv catheter system experienced leakage at the adapter septum.The following information was provided by the initial reporter: on (b)(6) 2020, the ct room nurse indwelling the patient with 20g straight pegasus in the middle of the elbow.After removing the needle , there was blood leakage at the end of the septum.The examination could be completed normally.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: (b)(6) 2020.H.6.Investigation: a device history review was conducted for lot number 0063013.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally the sample submitted to our facility was subjected to functional testing and microscopic visual analysis.The results of these tests show that the submitted device performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.
 
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Brand Name
BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key10804707
MDR Text Key216872546
Report Number3006948883-2020-00718
Device Sequence Number1
Product Code NGT
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 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383745
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2020
Initial Date Manufacturer Received 10/15/2020
Initial Date FDA Received11/06/2020
Supplement Dates Manufacturer Received12/14/2020
Supplement Dates FDA Received12/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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