MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX® ALL-SILICONE FOLEY CATHETER; SILICONE CATHETER

Model Number	166818
Health Effect - Clinical Code	No Information (3190)
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 the catheter was allegedly blocked, and urine did not flow to the bag.The nurse had to irrigate every two days.The catheter was inserted on (b)(6) 2017.The visual inspection noted there appeared to be calcification inside the catheter upon return.There appeared to be a cuff or partially inflated/raised section at the top of the balloon.
Additional Manufacturer Narrative
Upon further review and additional information, bard medical has determined that this mdr was initially reported in error as this event is not reportable.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 the catheter was allegedly blocked, and urine did not flow to the bag.The nurse had to irrigate every two days.The catheter was inserted on (b)(6) 2017.The visual inspection noted there appeared to be calcification inside the catheter upon return.There appeared to be a cuff or partially inflated/raised section at the top of the balloon.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6689086
• Report Number: 1018233-2017-03486
• Device Sequence Number: 532146
• Product Code: GBM
• UDI-Device Identifier: 00801741029813
• UDI-Public: (01)00801741029813
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K760093
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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
• Operator of Device: Health Professional
• Device Model Number: 166818
• Device Catalogue Number: 166818
• Device Lot Number: NGAU0504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1