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 Code	Pain (1994)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse attempted to remove foley catheter by withdrawing 5ml of saline water and tried to pull the foley catheter out of the patient.Nurse stated that they were able to remove the catheter until the tip of patient penis and then it got stuck.The nurse and doctor came into the room and attempted to remove, nurse pulled gently and the foley catheter was stuck and was painful for the patient.Doctor was able to twist the catheter slowly and the foley catheter came out.Nurse stated that on removal of the foley catheter it was found that the balloon was fully deflated and had a slight ridge in it.
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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿inadequate material selection¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿peel to open c.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com bardex® all-silicone foley catheter catheter shaft made entirely of silicone elastomer pd-50205 11/00 caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Bard and bardex are registered trademarks of c.R.Bard, inc.Or an affiliate.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Released" 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the nurse attempted to remove foley catheter by withdrawing 5ml of saline water and tried to pull the foley catheter out of the patient.Nurse stated that they were able to remove the catheter until the tip of patient penis and then it got stuck.The nurse and doctor came into the room and attempted to remove, nurse pulled gently and the foley catheter was stuck and was painful for the patient.Doctor was able to twist the catheter slowly and the foley catheter came out.Nurse stated that on removal of the foley catheter it was found that the balloon was fully deflated and had a slight ridge in it.

• 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: 12931176
• Report Number: 1018233-2021-07772
• Device Sequence Number: 3900594
• Product Code: KOD
• UDI-Device Identifier: 00801741029721
• UDI-Public: (01)00801741029721
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K821745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

1 Device was Involved in the Event

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: NGFU4500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 12/05/2021
• Supplement Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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 Sex: Unknown