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

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/15/2023

Event Type  malfunction  

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 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 Description

It was reported that patient had come into hospital due to a ltc being blocked.The patient current foley catheter was removed, and inserted a new catheter in.The foley catheter was draining well into a night bag until they realized it was leaking around the tube of the catheter and when inspecting the issue, they noticed that there was small hole or split in the catheter tubing.They removed the catheter and liaised with the doctors and nic the problem.They had to insert a second catheter into the patient and once the second catheter was in there was a noticeable amount of blood in the catheter from trauma of 2 consecutive catheter changes.No medical intervention was reported.

Event Description

It was reported that patient had come into hospital due to a ltc being blocked.The patient current foley catheter was removed, and inserted a new catheter in.The foley catheter was draining well into a night bag until they realized it was leaking around the tube of the catheter and when inspecting the issue, they noticed that there was small hole or split in the catheter tubing.They removed the catheter and liaised with the doctors and nic the problem.They had to insert a second catheter into the patient and once the second catheter was in there was a noticeable amount of blood in the catheter from trauma of 2 consecutive catheter changes.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "inadequate material selection".The device history record review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE 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: 18865355
• MDR Text Key: 337577647
• Report Number: 1018233-2024-01210
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other