MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. PRESTO INFLATION DEVICE

Catalog Number ID4030

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that prior to the procedure, the outer package was allegedly damaged.It was further reported that the inner package was allegedly damaged.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.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 10/2025).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 the procedure, the outer package was allegedly damaged.It was further reported that the inner package was allegedly damaged.There was no patient contact.

Manufacturer Narrative

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.Investigation summary: one presto device was returned for evaluation.The device was received in a presto white shipping box.Damage and tearing were noted to the white shipping box.The device was removed from the box, and damage was noted to the device packaging try and tyvek lid.The damage to the tyvek layer caused the sterile barrier to be torn and open at the location of the damage.Also, three electronic photos were provided for review.One photo shows an outer cardboard shipping box with bd tape on the side of the box.Major damage can be seen to the cardboard box, appearing to be crushed and torn.Another photo can show the presto white shipping box in a carboard box.Major damage and tearing can be seen to the white shipping box.A single presto device tray can be seen in the box, with the damage noted to the sterile tray appearing slightly crushed.The last photo shows a single device with damage to the tray and sterile tyvek layer.The damage caused a tear and breach to the sterile barrier.The damage is on the side of the device tray, and not near the location the sterile layer is pulled.The damage appears to be consistent with the crushed cardboard and white shipping box.Therefore, the investigation is confirmed for the reported packaging damage as damage was seen on the outer and inner packaging in both the provided photos and returned sample.The investigation is also confirmed for the breach of sterile barrier, as the breach was noted to the returned sample.Therefore, the likely root cause of the packaging damage and resulting breach of sterile barrier is the damage of the packaging during shipping.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: 10/2025), 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.

• Brand Name: PRESTO INFLATION DEVICE
• Type of Device: INFLATION DEVICE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): FOREFRONT MEDICAL TECHNOLOGY; changzhou ; CH
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18382962
• MDR Text Key: 331203043
• Report Number: 2020394-2023-01321
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K143522
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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: Health Professional
• Device Catalogue Number: ID4030
• Device Lot Number: ID2210180X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1