MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. TRUE FLOW DILATATION CATHETER; VALVULOPLASTY BALLOON CATHETER

Catalog Number	TF0243514
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No hospital/medical records or 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 been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that upon receiving the valvuloplasty balloon, the new label with a new expiration date was placed over an old label with an expiration date of over a year.There was no reported patient contact.
Event or Problem Description
It was reported that upon receiving the valvuloplasty balloon, the new label with a new expiration date was placed over an old label with an expiration date of over a year.There was no reported patient contact.
Additional Manufacturer Narrative
The device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.Although, it was indicated that the lot was over-labeled as the shelf life had been extended, there was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.The device was returned sealed in its inner packaging sleeve.The inner sleeve was returned in the outer box packaging.Both the inner sleeve and the outer box had been over-labeled with labeling referencing catalog number tf0243514, lot number gfbp3257a, and expiration date 2019-02-28.However, the new label on the end flap of the outer box had partially peeled away exposing the old label underneath.The only difference in product information between the old and new label was the expiration date.The outer label was identified to be the correct and current label based on the review of the lot history records.Therefore, the investigation is unconfirmed for a device marking issue, as the outer label and expiration date of 2019-02-28 is correct.However, as the outer label had peeled away from the box end flap, the investigation is confirmed for the reported labeling peeling off.It was determined that the reported lot had been over-labeled as the shelf life of the product had been extended to 2 years.It is unknown if the tears in the label occurred during shipping or while manipulating the end flap at the user facility.Therefore, the root cause for the reported peeling of the label could not be determined.The review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(b)(4).

• Brand Name: TRUE FLOW DILATATION CATHETER
• Common Device Name: VALVULOPLASTY BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7668019
• Report Number: 2020394-2018-01139
• Device Sequence Number: 1108138
• Product Code: OZT
• UDI-Device Identifier: 00801741097676
• UDI-Public: (01)00801741097676
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K152613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: 02/28/2019
• Device Catalogue Number: TF0243514
• Device Lot Number: GFBP3257A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1