MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER

Model Number	A319514AM
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient had a temperature sensing foley catheter in and it was noted that there was no urine output for the current hour compared to the previous hour.When looking at the 14fr balloon end, the balloon was ruptured and not intact, this particular foley was only placed several hours prior in the same day.New 14fr balloon temperature probe foley inserted without difficulty and patient did not experience any further issues.Per follow up via email on 04may2023, it was reported that the model# a319514am and lot# nggyr024, as of now, this was the only report they have received that has had this issue.Stated that the patient had no injury as a result and the catheter was disposed of when it was removed from the patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H3 other text: the device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be "wall thickness too thin".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.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 were found adequate and state the following: "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 patient record 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 (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed 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 resterilize.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." 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that patient had a temperature sensing foley catheter in and it was noted that there was no urine output for the current hour compared to the previous hour.When looking at the 14fr balloon end, the balloon was ruptured and not intact, this particular foley was only placed several hours prior in the same day.New 14fr balloon temperature probe foley inserted without difficulty and patient did not experience any further issues.Per follow up via email on 04may2023, it was reported that the model# a319514am and lot# nggyr024, as of now, this was the only report they have received that has had this issue.Stated that the patient had no injury as a result and the catheter was disposed of when it was removed from the patient.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16886191
• Report Number: 1018233-2023-03239
• Device Sequence Number: 12305589
• Product Code: MJC
• UDI-Device Identifier: 00801741073885
• UDI-Public: (01)00801741073885
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 12/31/2023
• Device Model Number: A319514AM
• Device Catalogue Number: 119314
• Device Lot Number: NGGYR024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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