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

Model Number	947516
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 2 hours after the foley catheter was placed there was no urine in the drainage bag.The complainant inspected the catheter and found that only a small amount of urine was present.The nurse reportedly pulled the catheter and had met no resistance.It was noted that when the catheter was removed a pinhole was present in the balloon.No medical intervention was reported.
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 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.
Event or Problem Description
It was reported that 2 hours after the foley catheter was placed there was no urine in the drainage bag.The complainant inspected the catheter and found that only a small amount of urine was present.The nurse reportedly pulled the catheter and had met no resistance.It was noted that when the catheter was removed a pinhole was present in the balloon.No medical intervention was reported.
Event or Problem Description
It was reported that 2 hours after the foley catheter was placed there was no urine in the drainage bag.The complainant inspected the catheter and found that only a small amount of urine was present.The nurse reportedly pulled the catheter and had met no resistance.It was noted that when the catheter was removed a pinhole was present in the balloon.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (no original packaging), used silicone foley.A 0.012" hole was noted in the balloon surface.This does not meet the specification as pinholes were not permitted.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be tooling damaged (core pins).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: "sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Proper techniques for urinary catheter insertion perform hand hygiene immediately before and after insertion insert urinary catheters using aseptic technique and sterile equipment use the smallest foley catheter possible, consistent with good drainage document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.Proper techniques for urinary catheter maintenance secure the foley catheter.Use the statlock® foley stabilization device if provided maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions maintain unobstructed urine flow and keep the catheter and collection tube free from kinking keep the collection bag below the level of the bladder or hips at all times empty the collection bag regularly using a separate, clean collection container for each patient.".

• Brand Name: BARDEX ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10199963
• Report Number: 1018233-2020-04111
• Device Sequence Number: 14054721
• Product Code: EZL
• UDI-Device Identifier: 00801741025044
• UDI-Public: (01)00801741025044
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2020

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: 10/03/2024
• Device Model Number: 947516
• Device Catalogue Number: 165816
• Device Lot Number: NGDX0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 06/04/2020; 08/10/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/02/2020; 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1