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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
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BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM Back to Search Results
Catalog Number 383711
Device Problems Difficult or Delayed Activation (2577); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/24/2020
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 needle was stuck when being retracted and the catheter was easily bent during use.The following information was provided by the initial reporter: when the functional neurosurgical nurse performed venipuncture for the patient, they found that the needle was blunt, it was feeling stuck when they were retracting the needle , and the retracting needle process could not be operating with puncturing the catheter at the same time, the catheter was also easy to be bent in the blood vessel.
 
Event Description
It was reported that bd pegasus¿ safety closed iv catheter system needle was stuck when being retracted and the catheter was easily bent during use.The following information was provided by the initial reporter: when the functional neurosurgical nurse performed venipuncture for the patient, they found that the needle was blunt, it was feeling stuck when they were retracting the needle , and the retracting needle process could not be operating with puncturing the catheter at the same time, the catheter was also easy to be bent in the blood vessel.
 
Manufacturer Narrative
H.6.Investigation summary a device history review was conducted for lot number 9201001.Our records show that this is the only instance of a 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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the units were 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.
 
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Brand Name
BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
CATHETER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
MDR Report Key10069879
MDR Text Key191750701
Report Number8041187-2020-00274
Device Sequence Number1
Product Code FPA
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 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2022
Device Catalogue Number383711
Device Lot Number9201001
Was Device Available for Evaluation? No
Date Manufacturer Received04/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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