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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
Catalog Number ID4030
Device Problems Unsealed Device Packaging (1444); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2023
Event Type  malfunction  
Event Description
It was reported that prior to an angioplasty procedure, the device packaging was allegedly unsealed.It was further reported that the device was allegedly stained with an unknown chemical substance.There was no patient contact.
 
Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2025).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that prior to an angioplasty procedure, the device packaging was allegedly unsealed.It was further reported that the device was allegedly stained with an unknown chemical substance.There was no patient contact.
 
Manufacturer Narrative
H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of four for this event.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Additionally, sterilization records were reviewed and this lot met all sterilization release criteria.Investigation summary: four presto devices were returned for evaluation.The devices were all received in a presto white shipping box.Damage to the shipping box was noted, however this appeared to be a result of shipping.Yellow staining was noted to the outer white yellow shipping box.The devices were removed from the box, and no evidence of contamination was noted to the device trays or sterile barrier.No contamination was seen on the physical devices.The seals of all 4 samples were noted to be intact and correctly sealed.Ftir and sem/eds analysis was performed on the yellow staining.The results of this testing were compared to manufacturing records, and no match to the material was able to be identified.The source of the staining could not be determined.Therefore, the investigation is confirmed for the reported contamination, as an unknown yellow staining was noted to the outer white shipping box.However the investigation is unconfirmed for the unsealed packaging, as no evidence of damage to the sterile barrier was noted to the 4 returned device samples.The definitive root cause for the reported contamination and unsealed packaging could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 11/2025), g3 , h6 (method).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
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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
Manufacturer (Section G)
FOREFRONT MEDICAL TECHNOLOGY
changzhou
CH  
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key17468809
MDR Text Key320517046
Report Number2020394-2023-00564
Device Sequence Number1
Product Code MAV
UDI-Device Identifier00801741095009
UDI-Public(01)00801741095009
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143522
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberID4030
Device Lot NumberID2211198X
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/21/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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