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

Model Number	300016A
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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.The device was not returned.
Event or Problem Description
It was reported that the urinary drain bag would not drain properly.Allegedly, the tube insert was not cut properly, subsequently urine did not flow into the bag.
Additional Manufacturer Narrative
The reported issue (it was reported that the urinary drain bag would not drain properly.Allegedly the tube insert was not cut properly, so the urine could not flow into the bag) was confirmed, as a manufacturing related issue.During the evaluation of the sample, it was noted that urine residues remained in the lower part of the bag and would not go through the outlet tube.The bag was cut in order to verify the occlusion and it could be confirmed that the perforation was missing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿ visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." correction: concomitant medical products and device evaluated by mfr.
Event or Problem Description
It was reported that the urinary drain bag would not drain properly.Allegedly, the tube insert was not cut properly, subsequently urine did not flow into the bag.

• Brand Name: BARDEX® I.C. COMPLETE CARE® 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: 7264243
• Report Number: 1018233-2018-00421
• Device Sequence Number: 11126606
• Product Code: MJC
• UDI-Device Identifier: 00801741000263
• UDI-Public: (01)00801741000263
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2018

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: 08/31/2019
• Device Model Number: 300016A
• Device Catalogue Number: 300016A
• Device Lot Number: NGBT1999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1