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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 INTRAVASCULAR CATHETER

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BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383914
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that there was a safety shield activation failure of a bd pegasus¿ safety closed iv catheter system. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: a photo was received for the purpose of our investigation. The investigators were able to observe the reported failure mode in the sample provided. Unfortunately the positioning of the v-clip could not be observed in the photo provided. A review of the device history record could not be performed as a lot number was not provided for this incident. Investigation conclusion: although the root cause could not be finalized without visually observing the positioning of the v-clip, previous investigations the most likely root cause of this failure mode is related to a tilted v-clip that caused inactivation of the device.
 
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Brand NameBD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key7542002
MDR Text Key109274060
Report Number8041187-2018-00154
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,health professional,o
Type of Report Initial,Followup
Report Date 06/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number383914
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/24/2018 Patient Sequence Number: 1
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