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

Model Number	365714
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Pain (1994); Distress (2329)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the foley catheter was inserted on (b)(6) 2021, attempted to remove on (b)(6) 2021, but was unable to be removed by deflating the balloon.The customer stated that only 7 ml of the 10 ml of fluid from the balloon was pulled back.Some fluid started to fill in the syringe automatically, but then stopped around the 4 to 5 ml mark.Manually user pulled back the remaining fluid until there was 7 ml in the syringe.But they were unable to remove any more fluid from the balloon.The removal of the foley was attempted, but there was significant resistance and pain expressed by the patient.An attempt was made to pop the foley balloon using a guidewire through the balloon port, but it was unsuccessful.Foley was removed via ultrasound guided needle popping of the foley catheter through the suprapubic route.The patient experienced significant pain and distress due to this incident.
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 the foley catheter was inserted on (b)(6)2021, attempted to remove on (b)(6)2021, but was unable to be removed by deflating the balloon.The customer stated that only 7 ml of the 10 ml of fluid from the balloon was pulled back.Some fluid started to fill in the syringe automatically, but then stopped around the 4 to 5 ml mark.Manually user pulled back the remaining fluid until there was 7 ml in the syringe.But they were unable to remove any more fluid from the balloon.The removal of the foley was attempted, but there was significant resistance and pain expressed by the patient.An attempt was made to pop the foley balloon using a guidewire through the balloon port, but it was unsuccessful.Foley was removed via ultrasound guided needle popping of the foley catheter through the suprapubic route.The patient experienced significant pain and distress due to this incident.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It was unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.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: ¿sterile unless package is opened or damaged.Do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricant having a petrolatum base.They will damage latex 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.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities: 3cc balloon: use 5cc sterile water.5cc balloon: use 10cc sterile water.15cc balloon: use 20cc sterile water.20cc balloon: use 25cc sterile water.30cc balloon: use 35cc sterile water.40cc balloon: use 45cc sterile water.75cc balloon: use 80cc sterile water.Do not exceed recommended capacities.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.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital.Protocol, the valve arm may be severed.If this fails, contact an 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.¿ 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.

• Brand Name: BARD® LUBRICATH® 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: 13561994
• Report Number: 1018233-2022-00723
• Device Sequence Number: 17192247
• Product Code: EZC
• UDI-Device Identifier: 00801741077739
• UDI-Public: (01)00801741077739
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 02/28/2026
• Device Model Number: 365714
• Device Catalogue Number: 365714
• Device Lot Number: MYFP2162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2021
• 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: Required Intervention
• Patient Sex: Unknown