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	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
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.However, as per additional information received from the ibc via email 11may2020; it was unknown how the catheter was removed from the patient.Per ibc sample evaluation the balloon looks to be intact.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.An amber lubricath irrigation catheter was returned without its original packaging.The catheter was inflated with 35 ccs of water.The shaft under the balloon was white.The catheter was then deflated with no issues.The investigation indicated that the reported event was unconfirmed.Therefore, a device history record review was not performed.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" ifus also states "visually inspect the product for any imperfections or surface deterioration prior to use.".
Event or Problem Description
It was reported that the catheter balloon was difficult to deflate some time after placement.However, as per additional information received from the ibc via email 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 01jun2020, the catheter was 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: 10074384
• Report Number: 1018233-2020-03291
• Device Sequence Number: 3358127
• 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): 07/24/2020

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: 03/18/2020
• 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: 04/28/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1