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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; N/A
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BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; N/A Back to Search Results
Catalog Number 383752
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem Blood Loss (2597)
Event Date 11/08/2019
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 was reported that bd pegasus¿ safety closed iv catheter system leaked blood.This was discovered during use.The following information was provided by the initial reporter: on (b)(6) 2019, it's noticed that blood leakage at the end cap.The patient has been diagnosed with hepatitis b.Nobody was exposed to blood/bodily fluid.
 
Event Description
It was reported that bd pegasus¿ safety closed iv catheter system leaked blood.This was discovered during use.The following information was provided by the initial reporter: on (b)(6) 2019, it's noticed that blood leakage at the end cap.The patient has been diagnosed with hepatitis b.Nobody was exposed to blood/bodily fluid.
 
Manufacturer Narrative
A device history review was conducted for lot number 9024961.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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
 
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Brand Name
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
N/A
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key9383486
MDR Text Key178632570
Report Number8041187-2019-00956
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 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2022
Device Catalogue Number383752
Device Lot Number9024961
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received11/27/2019
Supplement Dates Manufacturer Received11/12/2019
Supplement Dates FDA Received12/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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