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

Model Number	365712
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	02/21/2019
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 client's spouse contacted the home health office to inform them that the catheter had fallen out.The home care nurse attended the client and found the catheter out of the client with only part of the balloon.The balloon appeared to have ruptured and was not complete, which indicated that fragments of the balloon were retained in client's bladder.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.The evaluation found a balloon sac burst.The sample was evaluated under a microscope and no conditions were found that could be associated with the reported event.The exact cause could not be determined.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 clients spouse contacted the home health office to inform them that the catheter had fallen out.The home care nurse attended the client and found the catheter out of the client with only part of the balloon.The balloon appeared to have ruptured and was not complete, which indicated that fragments of the balloon were retained in client's bladder.
Additional Manufacturer Narrative
The device was not returned for evaluation.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." correction: concomitant medical products and device evaluated by mfr.
Event or Problem Description
It was reported that the client's spouse contacted the home health office to inform them that the catheter had fallen out.The home care nurse attended the client and found the catheter out of the client with only part of the balloon.The balloon appeared to have ruptured and was not complete, which indicated that fragments of the balloon were retained in client's bladder.

• 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: 8433023
• Report Number: 1018233-2019-01419
• Device Sequence Number: 13766436
• Product Code: EZC
• UDI-Device Identifier: 00801741077722
• UDI-Public: (01)00801741077722
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2019

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: Lay User/Patient
• Device Expiration Date: 01/01/2021
• Device Model Number: 365712
• Device Catalogue Number: 365712
• Device Lot Number: 6AJ7110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/16/2019; 06/25/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 05/06/2019; 06/26/2019
• 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: Required Intervention