MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLOWMATE PROCEDURAL KIT; CTO

Model Number	INJKIT
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that prior to a recanalization procedure, the expiration date in kit was allegedly not the same from date on the box.There was no patient contact.
Event or Problem Description
It was reported that prior to a recanalization procedure, the expiration date in kit was allegedly not the same from date on the box.There was no patient contact.
Additional 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 not been returned to the manufacturer for evaluation.However, a photo were provided for review.The investigation of the reported event is currently underway.H10: d4(expiry date: 07/2022), g3.H11: 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.
Additional 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: the physical device was not returned for evaluation.One electronic photo was provided and reviewed.The photo shows the flowmate procedural kit boxes and the components of the flowmate procedural kit.Per the drawing for the flowmate procedural kit, this is a kitted product and the original manufacturing labels do not get over labeled; the facility that packages the components only places a label on the master carton (outside box).The user should reference the label on the master carton for expiration date purposes.Therefore, the investigation is unconfirmed for the labeling issue.A definitive root cause for the alleged labeling issue 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 (expiry date: 07/2022), g3, h6 (method).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.
Event or Problem Description
It was reported that prior to a recanalization procedure, expiration date in the kit was allegedly not matching with the date on the box.There was no patient contact.

• Brand Name: FLOWMATE PROCEDURAL KIT
• Common Device Name: CTO
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15453457
• Report Number: 2020394-2022-00747
• Device Sequence Number: 5948709
• Product Code: DXT
• UDI-Device Identifier: 00801741067693
• UDI-Public: (01)00801741067693
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K903390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: INJKIT
• Device Catalogue Number: INJKIT
• Device Lot Number: REFT2431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 12/23/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/19/2022; 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown