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

Model Number	366716
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	01/11/2020
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was reported that it was difficult to deflate the balloon of the catheter.Reportedly, only 5 cc of fluid was able to be withdrawn from the catheter.When the catheter was removed, the balloon was still partially inflated.There was no reported patient injury.The catheter was not pretested.
Event or Problem Description
It was reported that it was difficult to deflate the balloon of the catheter.Reportedly, only 5 cc of fluid was able to be withdrawn from the catheter.When the catheter was removed, the balloon was still partially inflated.There was no reported patient injury.The catheter was not pretested.
Additional Manufacturer Narrative
The reported event was unconfirmed as the problem could not be reproduced.Evaluation found that the returned catheter could be inflated and deflated without difficulty.The catheter was dissected and found no conditions that could contribute to the reported event.Therefore, the reported event is unconfirmed based on the investigation findings.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: "caution: this product contains natural rubber latex which may cause allergic reactions.Pk6194321 4/03 rev.0 sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.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 and adequately trained professional for assistance, as directed by hospital protocol." h11:section a through f - 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.

• 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: 9726433
• Report Number: 1018233-2020-01109
• Device Sequence Number: 2886724
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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: 02/28/2024
• Device Model Number: 366716
• Device Catalogue Number: 366716
• Device Lot Number: 9FK032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1