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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PRESTO INFLATION DEVICE
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BARD PERIPHERAL VASCULAR, INC. PRESTO INFLATION DEVICE Back to Search Results
Model Number ID4030
Device Problem Deflation Problem (1149)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The lot number was provided for the malfunction and a lot history review will be performed.The device was returned for evaluation and the investigation is currently underway.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.The information reviewed indicated that model id4030 inflation device allegedly experienced deflation problem.The information was received from one source.The malfunction involved a patient with no reported consequences.Age, weight, and gender were not provided.
 
Event Description
This report summarizes one malfunction.The information reviewed indicated that model id4030 inflation device allegedly experienced deflation problem.The information was received from one source.The malfunction involved a patient with no reported consequences.Age, weight, and gender were not provided.
 
Manufacturer Narrative
H10: the lot number was provided, therefore a lot history review was performed.The sample was returned and the investigation is unconfirmed for the reported deflation issue.The device was labeled for single use.
 
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Brand Name
PRESTO INFLATION DEVICE
Type of Device
INFLATION DEVICE
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9965263
MDR Text Key189223237
Report Number2020394-2020-02781
Device Sequence Number1
Product Code MAV
UDI-Device Identifier00801741095009
UDI-Public(01)00801741095009
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/26/2020
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 No Information
Device Model NumberID4030
Device Catalogue NumberID4030
Device Lot NumberPID1903026
Initial Date Manufacturer Received 03/31/2020
Initial Date FDA Received04/15/2020
Supplement Dates Manufacturer Received06/26/2020
Supplement Dates FDA Received06/26/2020
Patient Sequence Number1
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