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

Model Number	366716
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Hematuria (2558); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2018
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 device was not returned.
Event or Problem Description
It was reported that the foley catheter balloon migrated into the urethra while it was still inflated.This event occurred after the foley catheter was stepped on.Allegedly, there was difficulty removing the catheter from the patient's urethra and the nurse was unable to deflate the balloon while using a 30cc syringe.Per additional information received from the ibc representative on (b)(6) 2018, the adult patient stepped on the foley catheter.The balloon migrated from his bladder into his urethra.The nurse removed the foley catheter while the balloon was still inflated and the patient had blood in his urine.
Additional Manufacturer Narrative
The reported event was found inconclusive due to the way the sample was received.The sample could not be inflated due to poor sample condition.No conditions were found on sample that could be associated with reported event.Due to the poor condition of the returned sample, a complete evaluation could not be performed.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: "single patient use only.Do not reuse.Do not resterilize.For urological use only.Visually inspect the product for any imperfections or surface deterioration prior to use.".
Event or Problem Description
It was reported that the foley catheter balloon migrated into the urethra while it was still inflated.This event occurred after the foley catheter was stepped on.Allegedly, there was difficulty removing the catheter from the patient's urethra and the nurse was unable to deflate the balloon while using a 30cc syringe.Per additional information received from the ibc representative on 26-oct-18, the adult patient stepped on the foley catheter.The balloon migrated from his bladder into his urethra.The nurse removed the foley catheter while the balloon was still inflated and the patient had blood in his urine.

• Brand Name: BARD® LUBRICATH® FOLEY CATHETER
• Common Device Name: HYDROGEL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8056849
• Report Number: 1018233-2018-05287
• Device Sequence Number: 2210940
• Product Code: KOD
• UDI-Device Identifier: 00801741077845
• UDI-Public: (01)00801741077845
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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: 03/28/2023
• Device Model Number: 366716
• Device Catalogue Number: 366716
• Device Lot Number: 8DJ5052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1