MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 30CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES; SILICONE CATHETER

Model Number	166818
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
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 catheter was blocked.; however, it is unknown if urine was returned.It was later reported that the urine did flow into the bag, although the nurse had to irrigate every two days.
Additional Manufacturer Narrative
The reported issue (that catheter was allegedly blocked.Apparently only inserted on (b)(6) 2017.It is unknown if urine was returned; additional information requested per additional information the urine did flow to the bag although the nurse had to irrigate every two days) was confirmed.Per visual inspection noted a lot of calcification inside the catheter, along the shaft.Per functional evaluation, water was not flowing through the catheter, therefore no flow was observed.The catheter was unable to drain due to the calcification inside.No manufacturing defects were found on the catheter.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: ¿caution: do not aspirate urine through drainage funnel wall.Single use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 catheter was blocked; however, it is unknown if urine was returned.It was later reported that the urine did flow into the bag, although the nurse had to irrigate every two days.

• Brand Name: BARDEX 2-WAY 30CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES
• 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: 6558566
• Report Number: 1018233-2017-02343
• Device Sequence Number: 18989436
• Product Code: EZL
• UDI-Device Identifier: 00801741029813
• UDI-Public: (01)00801741029813(10)NGAU0504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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 Expiration Date: 07/31/2021
• 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: 04/19/2017
• Supplement Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1