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

Model Number 0102L16

Device Problems Material Invagination (1336); Dent in Material (2526)

Patient Problem Pain (1994)

Event Date 07/13/2021

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 foley catheter deflated and folded onto itself developing strong ridges, hard balloon, and caused it to act as an obstruction.This was extremely painful to the patient and a challenge for the physician when the foley catheter was removed.The doctor stated that this has happened twice in the last week.There was no harm to patient.

Manufacturer Narrative

The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.A potential root cause for this failure could be "operator error.Dull cutting tools".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is confirmed manufacturing related.Correction: d,h 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 actual/suspected device was inspected.

Event Description

It was reported that the foley catheter deflated and folded onto itself developing strong ridges, hard balloon and caused it to act as an obstruction.This was extremely painful to the patient and became a challenge for the physician when the foley catheter was removed.The doctor stated that this has happened twice in the last week.There was no harm to the patient.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• Type of Device: FOLEY CATHETER TIEMANN MODEL COUDE
• 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: 12285990
• MDR Text Key: 265342772
• Report Number: 1018233-2021-04740
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018121
• UDI-Public: (01)00801741018121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

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 Model Number: 0102L16
• Device Catalogue Number: 0102L16
• Device Lot Number: NGFN4189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 02/10/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• 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