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

Model Number	0168SI14
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Code Available (3191)
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 tip of the foley broke in two pieces inside of the patient.A cystoscopy was done and the tip was not located inside of the patient, it was unknown as to the tips final destination.
Event or Problem Description
It was reported that the tip of the foley broke in two pieces inside of the patient.A cystoscopy was done and the tip was not located inside of the patient, it was unknown as to the tips final destination.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.A two way amber bardex catheter was returned with its tip missing.On closer examination, the tip appears to have experienced a bagger-like cut.The root cause of this failure is operator error in placing the catheter too far away from the marked line on the belt during the bagging process.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not completed as this failure only occurs in the manufacturing process and before the patient receives the device.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® I.C. CARSON MODEL COUDE TIP FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9341062
• Report Number: 1018233-2019-07388
• Device Sequence Number: 2145382
• Product Code: MJC
• UDI-Device Identifier: 00801741016950
• UDI-Public: (01)00801741016950
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 01/10/2024
• Device Model Number: 0168SI14
• Device Catalogue Number: 0168SI14
• Device Lot Number: MCDN0820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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