MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER

Model Number	0167L24
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.The device was not returned.
Event or Problem Description
It was reported that the foley catheter was lodged and did not move after an attempt to pull it out.15ml of fluid was removed from the balloon.A urology physician's assistant (pa) was called to assist with the removal.The balloon port was clipped by the pa , however was unable to remove the foley.The foley was eventually removed by urology.It was later reported via email on 30mar2020 that there were no additional procedures performed.It is unknown if the hospital stay was prolonged.
Event or Problem Description
It was reported that the foley catheter was lodged and did not move after an attempt to pull it out.15ml of fluid was removed from the balloon.A urology physician's assistant (pa) was called to assist with the removal.The balloon port was clipped by the pa , however was unable to remove the foley.The foley was eventually removed by urology.It was later reported via email on 30mar2020 that there were no additional procedures performed.It is unknown if the hospital stay was prolonged.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to the ¿kinked lumen".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.".

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9964699
• Report Number: 1018233-2020-02608
• Device Sequence Number: 3218140
• Product Code: KOD
• UDI-Device Identifier: 00801741018985
• UDI-Public: (01)00801741018985
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0167L24
• Device Catalogue Number: 0167L24
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other