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

Catalog Number 0165L12

Device Problems Break (1069); Material Rupture (1546); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheter fell out due to a balloon damage.No pieces were missing.

Manufacturer Narrative

The reported event was confirmed.Based on the evaluation, it was noted that pieces of the sac were missing, approximately (1.5cm x 2cm), resulting in balloon rupture with pieces left behind.The missing pieces were not returned.How and when event occurred could not be determine.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: "[warnings].1.Method for use.(1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients.Patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications].1.Method for use:.(1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients.(1) patients who are or have been allergic to natural rubber latex.(2) patients with known allergy to silver coated catheter." correction: d4.

Event Description

It was reported that the catheter fell out due to a balloon damage.No pieces were missing.Additional information was received from the international business center via email on 11apr19, that the balloon had burst and there were pieces missing from the balloon.No pieces were left in the patient; however, it was unknown how the pieces came out of the patient.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8453048
• MDR Text Key: 139975201
• Report Number: 1018233-2019-01546
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 0165L12
• Device Lot Number: 7MW8014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 04/13/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1