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

Model Number	0168L14
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2023
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.
Event or Problem Description
It was reported that the catheter got broken.About 25cm of the distal part of the catheter was retrieved, but the catheter tip had remained in the patient bladder which was recovered later.Per additional information received via investigators notification on 07mar2023, stated that the catheter fragment left behind in the patient's bladder was spontaneously discharged from the patient body on march 2.The sales representative recovered it on march 7.The patient was male.The patient was hospitalized in a psychiatric ward and he may have self-extracted the catheter.Per follow up information received from ibc on 08mar2023, catheter breakage.
Event or Problem Description
It was reported that the catheter got broken.About 25cm of the distal part of the catheter was retrieved, but the catheter tip had remained in the patient bladder which was recovered later.Per additional information received via investigators notification on 07mar2023, stated that the catheter fragment left behind in the patient's bladder was spontaneously discharged from the patient body on march 2.The sales representative recovered it on march 7.The patient was male.The patient was hospitalized in a psychiatric ward and he may have self-extracted the catheter.Per follow up information received from ibc on 08mar2023, catheter breakage.
Additional Manufacturer Narrative
The reported event is confirmed, cause unknown.The used two way foley catheter was returned without the original packaging.Photo samples were submitted showing the catheter broken into two separate pieces.Visual evaluation of the physical sample noted both broken pieces connected perfectly with each other, confirming no pieces missing from the catheter as a result of the break.As it is unclear if the patient self-extracted the catheter, this event will be confirmed cause unknown.As the event states the patient may have self extracted the catheter, potential root causes for this event could be, "user (patient) medicated, delirious, confused, or reckless" or "inadequate design".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: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients (1) patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.]" "to deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered." h11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER COUDE TIP
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16583156
• Report Number: 1018233-2023-01917
• Device Sequence Number: 11948880
• Product Code: EZC
• UDI-Device Identifier: 00801741017810
• UDI-Public: (01)00801741017810
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 12/31/2024
• Device Model Number: 0168L14
• Device Catalogue Number: 0168L14
• Device Lot Number: NGEQ4037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male