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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383721
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2018
Event Type  malfunction  
Manufacturer Narrative
A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the safety device on a bd pegasus¿ safety closed iv catheter system failed to function correctly. There was no report of exposure, injury or medical interventions.
 
Manufacturer Narrative
Investigation results: a sample/photo was not received for the purpose of our investigation, the investigators were unable to observe the reported failure mode. The batch record was reviewed, no related abnormalities were found. Although the root cause could not be determined without evidentiary support, previous investigations into this issue have shown that the v-clip becomes inactivated as a result of an external force being applied to the safety mechanism during the withdrawal of the cannula. This leads to the offset of the v-clip and unable to activate under normal condition.
 
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Brand NameBD PEGASUS¿ IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7371207
MDR Text Key103660475
Report Number8041187-2018-00078
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 04/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue Number383721
Device Lot Number6295058
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/26/2018 Patient Sequence Number: 1
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