MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VISILOC INTRODUCER SET; BIOPSY INSTRUMENT

Model Number	ECMRINTLOC
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.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.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that there was allegedly a 7 gauge coaxial introducer packaged in a box marked for a 10 gauge product.There was no reported patient injury.
Event or Problem Description
It was reported that there was allegedly a 7 gauge coaxial introducer packaged in a box marked for a 10 gauge product.There was no reported patient injury.
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.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Investigation summary: one visiloc introducer set was returned for evaluation.The inner packaging tray was received sealed referencing ecmrintloc7g within opened outer package referencing ecmrintloc.No damage was noted to the inner and outer packaging.A sales review was completed for the reporting facility and determined the facility has ordered and received both product codes between the months of july 2018 - october 2018.Although one 7g inner package was received within one 10g outer packaging, the facility ordered and received both gauge sizes and it is unknown how the devices are received and/or stored at the reporting facility; therefore the investigation is inconclusive for the alleged product mislabel.A definitive root cause could not be determined based upon the available information.

• Brand Name: VISILOC INTRODUCER SET
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8113460
• Report Number: 2020394-2018-02129
• Device Sequence Number: 11185792
• Product Code: KNW
• UDI-Device Identifier: 00801741086229
• UDI-Public: (01)00801741086229
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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 Expiration Date: 12/01/2018
• Device Model Number: ECMRINTLOC
• Device Catalogue Number: ECMRINTLOC
• Device Lot Number: VTCT0256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 11/28/2018
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1