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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 383711
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Inflammation (1932)
Event Date 09/16/2018
Event Type  Injury  
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 there was difficulty removing the bd pegasus¿ safety closed iv catheter system from the patient, and the puncture site was "red and showed potential phlebitis". After removal of the catheter, the puncture site was treated with "iodine fu disinfection". Medication of "the drug cephalosporin sodium, 5% glucose, (b)(6), electrolyte, vitamin b6, vitamin c" was administered, though it is unknown if these medications were being received before or after the possible ¿phlebitis¿. The phlebitis was reported to have ¿eased¿ the following day after catheter removal.
 
Event Description
It was reported that there was difficulty removing the bd pegasus¿ safety closed iv catheter system from the patient, and the puncture site was "red and showed potential phlebitis". After removal of the catheter, the puncture site was treated with "iodine fu disinfection". Medication of "the drug cephalosporin sodium, 5% glucose, yan hu ning, electrolyte, vitamin b6, vitamin c" was administered, though it is unknown if these medications were being received before or after the possible ¿phlebitis¿. The phlebitis was reported to have ¿eased¿ the following day after catheter removal.
 
Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 8044406. Records show it was assembled from 1/24/2018-1/29/2018, and determined that this is the only instance of difficult removal of a catheter occurring in this batch of product. 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 of packaged goods. The sample submitted by the facility was evaluated by our team of qualified quality investigators. No abnormalities were able to be identified in the tubing that could have resulted in the reported event. Unfortunately, the root cause for this complaint could not be determined at the conclusion of our review; bd will continue to track and trend for this issue.
 
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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 Key7957021
MDR Text Key123433009
Report Number8041187-2018-00363
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 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue Number383711
Device Lot Number8044406
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/11/2018 Patient Sequence Number: 1
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