MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER SILICONE COATED

Model Number	123512A
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)
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 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.The device was not returned.
Event or Problem Description
It was reported that the foley catheter broke after insertion.The foley catheter was filled with 10 cc of sterile water and the catheter then fell out of the patient; however, the balloon was no longer attached to the catheter.The patient was admitted to the hospital; however, it is unknown at this time what treatment the patient received.
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 foley catheter broke after insertion.The foley catheter was filled with 10cc of sterile water and the catheter then fell out of the patient; however, the balloon was no longer attached to the catheter.The patient was admitted to the hospital; however, it is unknown at this time what treatment the patient received.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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.]".
Event or Problem Description
It was reported that the foley catheter broke after insertion.The foley catheter was filled with 10cc of sterile water and the catheter then fell out of the patient; however, the balloon was no longer attached to the catheter.The patient was admitted to the hospital; however, it is unknown at this time what treatment the patient received.

• Brand Name: BARDIA® FOLEY CATHETER SILICONE COATED
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7741898
• Report Number: 1018233-2018-03233
• Device Sequence Number: 1510972
• Product Code: EZC
• UDI-Device Identifier: 00801741095078
• UDI-Public: (01)00801741095078
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2018

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?: No
• Operator of Device: Other
• Device Expiration Date: 08/28/2022
• Device Model Number: 123512A
• Device Catalogue Number: 123512A
• Device Lot Number: MYBYR373
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 07/11/2018; 08/06/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 08/02/2018; 08/29/2018
• 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: Hospitalization; Other
• Patient Age: 9 YR