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

Model Number	01237524
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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.The device was not returned.
Event or Problem Description
It was reported that the customer had two issues this week with defective foley catheters.The first one had a small leak.The second one had a balloon that broke.Per follow up made on 12mar2021, initially it was reported that the balloon burst on the second patient, but when tested it was noted that the balloon was intact and the leak was inside the balloon and no pieces were missing.The second one was inflated to 80ml with saline water.Per additional information via email on 17mar2021, customer mentioned that they had one more balloon burst.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "bad fit with connector".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: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.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 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 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 customer had two issues this week with defective foley catheters.The first one had a small leak.The second one had a balloon that broke.Per follow up made on 12mar2021, initially it was reported that the balloon burst on the second patient, but when tested it was noted that the balloon was intact and the leak was inside the balloon and no pieces were missing.The second one was inflated to 80ml with saline water.Per additional information via email on 17mar2021, customer mentioned that they had one more balloon burst.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11592439
• Report Number: 1018233-2021-01729
• Device Sequence Number: 19572087
• Product Code: EZC
• UDI-Device Identifier: 00801741017742
• UDI-Public: (01)00801741017742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K910195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2021

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 01237524
• Device Catalogue Number: 01237524
• Device Lot Number: NGEU2822
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other