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

Model Number	INJKIT
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 11/2020).
Event or Problem Description
It was reported that prior to recanalization procedure, the kit and individual packaging expiry dates were allegedly mismatching.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the physical device was not returned for evaluation.However, five photos were sent for review.The photos show the components that make up the flow mate procedural kit.Per the drawing for the flow mate procedural kit (document number: injkit), 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 label on the master carton is the only label that should be referenced for expiration date purposes.Therefore, the investigation is unconfirmed for the labeling issue.The definitive root cause for the reported material rupture could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4(expiry date: 11/2020).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.H3 other text : device not returned.
Event or Problem Description
It was reported that prior to recanalization procedure, the kit and individual packaging expiry dates were allegedly mismatching.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
• MDR Report Key: 11085512
• Report Number: 2020394-2020-20957
• Device Sequence Number: 14343047
• Product Code: DXT
• UDI-Device Identifier: 00801741067693
• UDI-Public: (01)00801741067693
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K903390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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
• Operator of Device: Health Professional
• Device Model Number: INJKIT
• Device Catalogue Number: INJKIT
• Device Lot Number: REDV3821
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other