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

Model Number	119214M
Medical Device Problem Codes	Deflation Problem (1149); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event is unconfirmed since the reported failure could not be reproduced.Visual evaluation of the sample noted one opened (without original packaging) meter bag, drainage tubing and temperature sensing silicone foley and sample port connector.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.Active length of the catheter balloon was measured (0.7655") and found to be within specification (0.6"-0.9").The catheter was confirmed to be 14 fr.A potential root cause could not be found since the reported event was unconfirmed.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: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.".
Event or Problem Description
It was reported that the temperature sensing foley deflated prematurely and fell out of the patient.
Event or Problem Description
It was reported that the temperature sensing foley deflated prematurely and fell out of the patient.It was later reported from the facility that the balloon was not deflated when the catheter fell out of the patient.
Additional Manufacturer Narrative
The reported event was unconfirmed since the reported failure could not be reproduced.Visual evaluation of the sample noted one opened (without original packaging) meter bag, drainage tubing and temperature sensing silicone foley and sample port connector.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.Active length of the catheter balloon was measured (0.7655") and found to be within specification (0.6"-0.9").The catheter was confirmed to be 14 fr.A potential root cause could not be found since the reported event was unconfirmed.A device history record review was not required per the investigation.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to 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: TEMP SENSING FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8901825
• Report Number: 1018233-2019-04823
• Device Sequence Number: 18888965
• Product Code: EZL
• UDI-Device Identifier: 00801741046292
• UDI-Public: (01)00801741046292
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 09/13/2023
• Device Model Number: 119214M
• Device Catalogue Number: 119214M
• Device Lot Number: NGCT1115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1