MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY

Model Number	903016A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 product 903016a was ordered; however, when the shipment was received, the box contained product 902916 instead.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 product 903016a was ordered; however, when the shipment was received, the box contained product 902916 instead.
Additional Manufacturer Narrative
Received one opened case sample with 9 unopened trays inside.The reported event was confirmed.This was a post manufacturing related issue and did not occur while it was manufactured and shipped out from bmd nogales.During the visual evaluation, the information of the label attached to the box was reviewed.The label specifies product number 903016a, lot number ngax4017.The box contained nine trays inside.However, the nine trays had an insert sheet with product number 902916, lot number ngaz3382.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that product 903016a was ordered; however, when the shipment was received, the box contained product 902916 instead.The box came through owens & minor from bard.
Additional Manufacturer Narrative
Received one opened case sample with 9 unopened trays inside.The reported event was confirmed.This was a post manufacturing related issue and did not occur while it was manufactured and shipped out from (b)(4).During the visual evaluation, the information of the label attached to the box was reviewed.The label specifies product number 903016a, lot number ngax4017.The box contained nine trays inside.However, the nine trays had an insert sheet with product number 902916, lot number ngaz3382.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).
Event or Problem Description
It was reported that product 903016a was ordered; however, when the shipment was received, the box contained product 902916 instead.The box came through owens & minor from bard.

• Brand Name: BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6540501
• Report Number: 1018233-2017-02257
• Device Sequence Number: 83627
• Product Code: MJC
• UDI-Device Identifier: 00801741019876
• UDI-Public: (01)00801741019876(10)NGAX4017
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2018

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 Model Number: 903016A
• Device Catalogue Number: 903016A
• Device Lot Number: NGAX4017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2017
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided; 08/02/2017; 01/26/2018
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 05/04/2017; 08/09/2017; 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1