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

Model Number	942208
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2017
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 the catheter leaked urine from the tubing, near the "hub", below the balloon, for twenty seconds.Subsequently, the device was replaced.The nurse reported that the patient needed a foley catheter for chemotherapy, and ativan was given prior to placing the foley.
Additional Manufacturer Narrative
Received 1 drainage bag with catheter and packaging label.The reported event was confirmed as manufacturing related.Per the visual inspection of the received sample, no obvious defects were noted.Per the functional evaluation, water was injected by drainage lumen and leakage was noted by a cut below the bifurcation area on the drainage lumen.The cut from the bifurcation area on the drainage lumen measured 1/16¿ (0.0625¿).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".(b)(4).
Event or Problem Description
It was reported that the catheter leaked urine from the tubing, near the "hub", below the balloon, for twenty seconds.Subsequently, the device was replaced.The nurse reported that the patient needed a foley catheter for chemotherapy, and ativan was given prior to placing the foley.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Common Device Name: LUBRI-SIL CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6675386
• Report Number: 1018233-2017-03330
• Device Sequence Number: 919687
• Product Code: EZL
• UDI-Device Identifier: 00801741029370
• UDI-Public: (01)00801741029370
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K984084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2017

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: 03/08/2021
• Device Model Number: 942208
• Device Catalogue Number: 175808
• Device Lot Number: NGZI4217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1