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

Model Number	365714
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the foley catheter was difficult to deflate after completion of a medication regimen.Only 6 cc was able to be removed from the balloon upon removal attempt.The foley continued to function and drain urine.The inflation port was cut and air did not come out of the balloon.The balloon was ultimately punctured and deflated by the healthcare provider.Per additional information received from the complainant via email on 12feb2021, the device was removed with a percutaneous puncture by the urologist.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this failure mode could be user related, example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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 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.Note: after use, this product may be a potential bio hazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle." 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.
Event or Problem Description
It was reported that the foley catheter was difficult to deflate after completion of a medication regimen.Only 6 cc was able to be removed from the balloon upon removal attempt.The foley continued to function and drain urine.The inflation port was cut and air did not come out of the balloon.The balloon was ultimately punctured and deflated by the healthcare provider.Per additional information received from the complainant via email on (b)(6) 2021, the device was removed with a percutaneous puncture by the urologist.

• 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: 11423970
• Report Number: 1018233-2021-01028
• Device Sequence Number: 11716189
• Product Code: EZC
• UDI-Device Identifier: 00801741077739
• UDI-Public: (01)00801741077739
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 365714
• Device Catalogue Number: 365714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/19/2021
• 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: Required Intervention
• Patient Age: 33 YR