MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER; SURESTEP TRAY

Model Number	A119214M
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
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.
Event or Problem Description
It was reported that the cord on the temperature sensor had eroded through the shaft of the foley, near the 3-way port.It was noticed when the nurse was assessing the patient.It was immediately removed and there was no harm was done to the patient.No medical intervention was reported.
Event or Problem Description
It was reported that the cord on the temperature sensor had eroded through the shaft of the foley, near the 3-way port.It was noticed when the nurse was assessing the patient.It was immediately removed and there was no harm was done to the patient.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one opened (no original packaging), used silicone foley.It was noted that at some points on the shaft near the trifurcation, the wire was irregularly coiled and penetrated and protruded out from the shaft.This did not meet the specification "the wire should not be kinked, knotted or broken once is inserted in the lumen".Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be short shaft/long thermistor.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.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.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." h11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Common Device Name: SURESTEP TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10051316
• Report Number: 1018233-2020-03167
• Device Sequence Number: 10956733
• Product Code: EZL
• UDI-Device Identifier: 00801741073670
• UDI-Public: (01)00801741073670
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 11/30/2021
• Device Model Number: A119214M
• Device Catalogue Number: 119214M
• Device Lot Number: NGDW2512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1