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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER
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BD (SUZHOU) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER Back to Search Results
Catalog Number 383954
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 11/03/2020
Event Type  malfunction  
Manufacturer Narrative
Medical device lot #: the initial reporter provided an invalid lot #: of 916676.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that 6 bd pegasus¿ safety closed iv catheter systems experienced a mix of product types in a pack.The following information was provided by the initial reporter: a box of 25 products should be equipped with safety needles, but 6 of them were mixed with the normal pegasus, which had no connector.
 
Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 9166769.Our records were not able to associate lot number 9166769.Since the lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event.H3 other text : see h10.
 
Event Description
It was reported that 6 bd pegasus¿ safety closed iv catheter systems experienced a mix of product types in a pack.The following information was provided by the initial reporter: a box of 25 products should be equipped with safety needles, but 6 of them were mixed with the normal pegasus which had no connector.
 
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Brand Name
BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
Type of Device
INTERVASCULAR CATHETER
Manufacturer (Section D)
BD (SUZHOU)
no. 5 baiyu road
suzhou industrial park
suzhou
MDR Report Key10910031
MDR Text Key221261133
Report Number3006948883-2020-00853
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,other,user facility
Type of Report Initial,Followup
Report Date 02/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number383954
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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