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

Model Number 165816

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2022

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 there was the mushroom shaped foley catheter balloon on the 4th day of use.The patient had been using the device for many years and this had never happened before.Per follow up via ibc on 19may2022, the kaflor referred to mushroom shaped balloon.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was used for treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter with cut portion of inlet tubing.Visual inspection of the sample noted no obvious visible defects.The catheter balloons were inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 70:30 as compared.This meets specification as concentricity should not exceed 70:30 and was allowed to rest with no observed leaks.The catheter balloon was deflated with no issues or cuffing noted.This meet specification per inspection procedure which states, "balloon must not cuff after deflation in accordance ".No root cause could be found because the reported event was unconfirmed.The device history record review and labeling review was not required as the reported event was unconfirmed.The actual/suspected device was inspected.

Event Description

It was reported that there was the mushroom shaped foley catheter balloon on the 4th day of use.The patient had been using the device for many years and this had never happened before.Per follow up via ibc on 19may2022, the kaflor referred to mushroom shaped balloon.

• Brand Name: BARDEX® ALL-SILICONE FOLEY 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14516295
• MDR Text Key: 292795964
• Report Number: 1018233-2022-04133
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGFQ2657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 10/28/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• 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