MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX® I.C. COMPLETE CARE® FOLEY TRAY; DRAINAGE BAG

Catalog Number 900014A

Device Problems Break (1069); No Flow (2991)

Patient Problem No Code Available (3191)

Event Date 04/29/2017

Event Type  malfunction  

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 Description

It was reported that urine did not flow into the meter, as the right angle tube under the chamber of the drainage bag was broken.It was allegedly hanging on the bed and was in use for 12 days.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.

Event Description

It was reported that urine did not flow into the meter, as the right angle tube under the chamber of the drainage bag was broken.It was allegedly hanging on the bed and was in use for 12 days.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Type of Device: DRAINAGE BAG
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6589878
• MDR Text Key: 76032029
• Report Number: 1018233-2017-02661
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 900014A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: 11/02/2017
• Supplement Dates FDA Received: 11/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1