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

Model Number	0102L14
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	05/17/2021
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 there was an issue regarding a 14fr coude foley that was unable to deflate.They ended up having to cut the one-way valve to deflate the balloon.The patient did not suffer any ill effects and the package of the foley was discarded.Per additional information received on 14jan2021, it was reported that again a 14 french coude was unable to deflate the balloon.The user had to cut the valve but that did not work.The patient had to go to research way to have it deflated.The urologist passed a wire through the foley and deflated the balloon.The urologist said that there was a manufacturing defect about half way up the catheter.Also, the customer had 6 additional unused catheters from the cancer center.The patient had to leave the cancer center and was taken to the clinic for removal.Per follow up response received on 20jan2021, the patient¿s treatment was delayed, and the patient was not harmed due to excellence in care and rescue efforts.The patient was inconvenienced and need to be transferred off site to one of our clinics to have the catheter removed, and additional costs were incurred by the facility.Per additional formation received on 17may2021, stated that 14fr coude foley that was unable to deflate with several interventions as per the urology pa with no success.Patient went to urology department for the foley catheter to be removed.Per follow up received on 20may2021, the patient had to go to an off site location to have the foley removed.The urologist inserted a guide wire into the foley and deflated the balloon.There was no harm to the patient.The foley was in place for almost 3 hours.The foley was inflated with 10 ccs.The foley had bacillus calmette-guérin in it and was discarded in a biohazard container.The foley was removed with that same lot number - ngex4857.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The devices did not fail to meet relevant specifications.The products were used for treatment purposes.The products had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A dhr review is not required as the event is unconfirmed.As the reported event is unconfirmed a labeling review is not required.H11: section a through f - 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.
Event or Problem Description
It was reported that there was an issue regarding a 14fr coude foley that was unable to deflate.They ended up having to cut the one-way valve to deflate the balloon.The patient did not suffer any ill effects and the package of the foley was discarded.Per additional information received on 14jan2021, it was reported that again a 14 french coude was unable to deflate the balloon.The user had to cut the valve but that did not work.The patient had to go to research way to have it deflated.The urologist passed a wire through the foley and deflated the balloon.The urologist said that there was a manufacturing defect about half way up the catheter.Also, the customer had 6 additional unused catheters from the cancer center.The patient had to leave the cancer center and was taken to the clinic for removal.Per follow up response received on 20jan2021, the patient¿s treatment was delayed, and the patient was not harmed due to excellence in care and rescue efforts.The patient was inconvenienced and need to be transferred off site to one of our clinics to have the catheter removed, and additional costs were incurred by the facility.Per additional formation received on 17may2021, stated that 14fr coude foley that was unable to deflate with several interventions as per the urology pa with no success.Patient went to urology department for the foley catheter to be removed.Per follow up received on 20may2021, the patient had to go to an off site location to have the foley removed.The urologist inserted a guide wire into the foley and deflated the balloon.There was no harm to the patient.The foley was in place for almost 3 hours.The foley was inflated with 10 ccs.The foley had bacillus calmette-guérin in it and was discarded in a biohazard container.The foley was removed with that same lot number - ngex4857.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11971583
• Report Number: 1018233-2021-03363
• Device Sequence Number: 17198345
• Product Code: EZC
• UDI-Device Identifier: 00801741018114
• UDI-Public: (01)00801741018114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 11/11/2021

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: 07/31/2025
• Device Model Number: 0102L14
• Device Catalogue Number: 0102L14
• Device Lot Number: NGEX4857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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: Required Intervention
• Patient Sex: Unknown