MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER; 3 WAY IRRIGATION FOLEY CATHETER

Model Number	0125RL22
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Insufficient Information (4580)
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.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 3 way irrigation foley catheter balloon had deflation issue.Additional information is required.Follow up via email on (b)(6) 2020, the catheter deflated and came out while the patient was in pacu (post anesthetic care unit) post surgical insertion.Catheter balloon was rechecked and it was found out of patient(self deflated); the balloon slowly deflated when air was inserted and it was found that there was no visible hole (appears patent).The patient had to return (2nd take back)for surgery per the urologist for blood clot evacuation/evaluation and for reinsertion of the catheter.Balloon was inflated with sterile normal saline per operation room(or) nurse.Per surgeon the balloon was inflated with 45ml.
Event or Problem Description
It was reported, that the 3 way irrigation foley catheter balloon had deflation issue.Per follow up via email on (b)(6) 2020, the catheter deflated and came out, while the patient was in pacu (post anesthetic care unit) post surgical insertion.Catheter balloon rechecked, after found out of patient(self deflated).Rechecked after- slowly deflates when air inserted-no visible hole (appears patent).The patient had to return (2nd take back) to surgery.Per the urologist, for blood clot evacuation/evaluation and reinsertion of catheter.Balloon was inflated with sterile normal saline per or nurse.Per surgeon, the balloon was inflated with 45ml.
Additional Manufacturer Narrative
The reported event was confirmed, as manufacturing-related.An irrigation red rubber lubricath foley was without its original packaging.The device was inflated with 35ccs of deionized water.Water was found, coming out of drainage eye and the irrigation funnel confirming, a lumen to lumen leak.A potential root cause of the lumen to lumen leak could be, due to an over filling of the dip tank.The device history record was reviewed, and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event was found to be, due to a manufacturing related issue.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: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: 3 WAY IRRIGATION FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10582618
• Report Number: 1018233-2020-06199
• Device Sequence Number: 304639
• Product Code: KOD
• UDI-Device Identifier: 00801741019166
• UDI-Public: (01)00801741019166
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: 06/11/2022
• Device Model Number: 0125RL22
• Device Catalogue Number: 0125RL22
• Device Lot Number: MCBT1489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 02/16/2021
• 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