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

Model Number ID4030

Device Problems Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

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.(expiration date: 06/2024).

Event Description

It was reported that prior to an angioplasty procedure, the box of the device allegedly arrived broken.There was no patient contact.

Event Description

It was reported that prior to an angioplasty procedure, the box of the device allegedly arrived broken.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 unsealed presto inflation device package with one unsealed lot sample was received for evaluation.During visual evaluation, the outer packaging box was noted to be damaged with tears to the bottom right and back side of the box.The returned lot sample packaging was noted to be opened and with multiple damage to the tyvek tray.No damage was noted to the presto device.No functional testing was due to the nature of the complaint.Four photos were provided and reviewed.The first photo shows the presto inflation device inner packaging which is noted to be opened and with damage to the tyvek tray.The second photo shows the outer packaging box which is noted to be damaged with tears to the box.The third photo shows the presto inflation device inner packaging which is noted to be opened and with damage to the tyvek tray.The fourth photo shows the presto inflation device inner packaging which is noted to be opened and with damage to the tyvek tray.No damage was noted to the presto device and no other specific anomalies noted.Therefore, the investigation is confirmed for the reported packaging problem as the outer packaging box and inner packaging of the device are noted to be damaged in both the provided photos and the returned sample.The investigation is also confirmed for the reported breach of sterile barrier as the inner packaging was noted to be opened and with damage to the tyvek tray in both the provided photos and the returned sample.A definitive root cause for the alleged packaging problem and breach of sterile barrier could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 06/2024), g3, h6(method).H11: g1, h6(device, result, conclusion).H11: section a through f - the information provided by bd represents all of 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.H3 other text : see h10.

• 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 Key: 13683951
• MDR Text Key: 286743459
• Report Number: 2020394-2022-00147
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 00801741095009
• UDI-Public: (01)00801741095009
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/28/2022

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 Model Number: ID4030
• Device Catalogue Number: ID4030
• Device Lot Number: ID2106078X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/07/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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