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

Model Number	365718
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ''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.''.
Event or Problem Description
It was reported that a 18fr foley catheter was placed in the emergency department and it was removed by the urology three days later in medical intensive care unit.It was stated that when they attempted to empty the foley balloon with an empty syringe, they were only able to get 4 ml out and the catheter was collapsing, it was unable to remove anymore.It was reported that they were unable to pull foley due to resistance and the patient complained of pain and the urology had to remove at bedside.No medical intervention was reported.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bard 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that a 18fr foley catheter was placed in the emergency department and it was removed by the urology three days later in medical intensive care unit.It was stated that when they attempted to empty the foley balloon with an empty syringe, they were only able to get 4 ml out and the catheter was collapsing, it was unable to remove anymore.It was reported that they were unable to pull foley due to resistance and the patient complained of pain and the urology had to remove at bedside.No medical intervention was reported.

• Brand Name: BARD LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12494842
• Report Number: 1018233-2021-05779
• Device Sequence Number: 20187004
• Product Code: EZC
• UDI-Device Identifier: 00801741077753
• UDI-Public: (01)00801741077753
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2021

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 Model Number: 365718
• Device Catalogue Number: 365718
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/08/2021
• 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: Other