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

Model Number	165810
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
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.
Event or Problem Description
It was reported that the 10 fr all-silicone foley catheter balloon was stuck upon removal after 5 days from placement.It was stated that the balloon was cuffed, which leads to difficulty in removing the catheter.The urologist who placed the catheter had no issues with placement, even though others failed, and instilled 5 ml of water as recommended.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that the 10 fr all-silicone foley catheter balloon was stuck upon removal after 5 days from placement.It was stated that the balloon was cuffed, which leads to difficulty in removing the catheter.The urologist who placed the catheter had no issues with the placement, even though others failed, and instilled 5 ml of water as recommended.Per additional information received via sample form on 19jan2022, it was stated that the patient experienced pain when the foley catheter was removed and stated that significant manipulation and additional lubrication was required to remove.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.The reported failure is considered out of specification as the reported failure was reproduced.The product was used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used pediat all silicone foley.Visual inspection of the sample noted the balloon mushroomed on the return sample.This does not meet the specification, revision 29 stating that "balloon must not cuff after deflation in accordance to w76qa010." a potential root cause for this failure mode could be ¿ balloon material does not shrink quickly enough".Based on information in the fmea, the residual risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the 10 fr all-silicone foley catheter balloon was stuck upon removal after 5 days from placement.It was stated that the balloon was cuffed, which leads to difficulty in removing the catheter.The urologist who placed the catheter had no issues with the placement, even though others failed, and instilled 5 ml of water as recommended.Per additional information received via sample form on 19jan2022, it was stated that the patient experienced pain when the foley catheter was removed and stated that significant manipulation and additional lubrication was required to remove.

• Brand Name: BARDEX® PEDIATRIC ALL-SILICONE FOLEY CATHETER
• 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: 12579606
• Report Number: 1018233-2021-06231
• Device Sequence Number: 14739335
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K821745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Model Number: 165810
• Device Catalogue Number: 165810
• Device Lot Number: NGFR0366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 01/19/2022; 03/17/2022
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 02/09/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• 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 Age: 6 YR
• Patient Sex: Unknown