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

Model Number	73016L
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 the catheter leaked near the 3 way valve.
Additional Manufacturer Narrative
Received 1 silicone catheter with the original packaging.The reported event was confirmed as manufacturing related.Per the visual inspection, no defects were found.Per the functional evaluation, the sample was inflated with 35cc with a mix of blue methylene and tap water and no leakage was observed by the inflation lumen.Then, the drainage and irrigation lumens were tested and a leakage was observed by the irrigation lumen at trifurcation.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." 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 leaked near the 3 way valve.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: LUBRISIL FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6615994
• Report Number: 1018233-2017-02948
• Device Sequence Number: 739440
• Product Code: EZL
• UDI-Device Identifier: 00801741034299
• UDI-Public: (01)00801741034299(17)211130(10)NGAX3334
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070558
• 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): 07/26/2017

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: 10/31/2021
• Device Model Number: 73016L
• Device Catalogue Number: 73016L
• Device Lot Number: NGAX0496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1