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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER; INTRAVASCULAR CATHETER
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BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER; INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 383735
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 50 bd pegasus¿ safety closed iv catheters had difficult needle disengagement during use.The following information was provided by the initial reporter, translated from chinese to english: "in the process of using the product, the user found that the back needle stuck, and even one or two will bring out the catheter tube, five other products were found unable to unscrew the cap of heparin during the completion and maintenance process".
 
Event Description
It was reported that 50 bd pegasus¿ safety closed iv catheters had difficult needle disengagement during use.The following information was provided by the initial reporter, translated from chinese to english: "in the process of using the product, the user found that the back needle stuck, and even one or two will bring out the catheter tube, five other products were found unable to unscrew the cap of heparin during the completion and maintenance process.".
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 9050858.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.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 results of these show that the tested units 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.H3 other text : see h.10.
 
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Brand Name
BD PEGASUS SAFETY CLOSED IV CATHETER
Type of Device
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key11098320
MDR Text Key224860415
Report Number3006948883-2020-01067
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
NA
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 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/09/2023
Device Catalogue Number383735
Device Lot Number0078893
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/02/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received01/22/2021
Supplement Dates FDA Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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