MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL; BARDEX 3 WAY FOLEY LATEX CATHETER

Model Number	0134L18
Medical Device Problem Code	Component Misassembled (4004)
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 catheter balloon was difficult to deflate some time after placement.Per additional information from the ibc via email 11may2020, it was unknown how the catheter was removed from the patient.Per ibc sample evaluation, the balloon looked to intact.Per sample evaluation on (b)(6) 2020, the catheter was found to be missing an irrigation eye.
Additional Manufacturer Narrative
The reported event was confirmed, as a manufacturing-related.An amber lubricath irrigation catheter was returned without its original packaging.It was found that the irrigation eye was missing.The reported event was confirmed as a manufacturing-related issue based on the investigation findings.The manufacturing review would indicate a possible manufacturing issue that could be related to the reported event.The device history record was reviewed and found a possible manufacturing issue 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.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 15cc balloon: use 20ml sterile water 20cc balloon: use 25ml sterile water 30cc balloon: use 35ml sterile water 40cc balloon: use 45ml sterile water 75cc balloon: use 80ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.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.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 catheter balloon difficult to deflate some time after the placement.Per additional information received from the ibc via email on 11may2020, it was unknown how the catheter was removed from the patient.Per ibc sample evaluation, the balloon looks to be intact.Per sample evaluation on 01jul2020, the catheter found to be missing an irrigation eye.

• Brand Name: BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL
• Common Device Name: BARDEX 3 WAY FOLEY LATEX CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10308921
• Report Number: 1018233-2020-04701
• Device Sequence Number: 11634010
• Product Code: KOD
• UDI-Device Identifier: 00801741018756
• UDI-Public: (01)00801741018756
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/29/2020

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: 03/18/2024
• Device Model Number: 0134L18
• Device Catalogue Number: 0134L18
• Device Lot Number: MCDP6014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1