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

Model Number 119112

Device Problem Difficult to Remove (1528)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

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 catheter balloon was difficult to deflate during pretest.

Event Description

It was reported that the catheter balloon was difficult to deflate during the pretest.

Manufacturer Narrative

The reported event was confirmed as a manufacturing related.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted one opened (without original package) used temperature sensing silicone foley catheter was received.Visual inspection of the sample noted that the catheter balloon was difficult to inflate.The inflation notch was visible through the catheter balloon and it could be seen not completely perforated.The balloon was dissected and the inflation notch was found not be punched deep enough.The device did not meet the specifications.The product was not used for the treatment purposes.The product had caused the reported failure.A potential root cause for this failure mode could be due to tool wear of the notch puncher.No preventive maintenance to verify the correct functionality of the puncher knife.The lifetime for knife and replacement control.Incorrect positioning of the shaft into the punching machine.Manufacturing procedure did not address the visual aids as a support for production operators.Detection or control method was not enough for failure detection.Per investigation a labeling review was not required.H11:section a through f - the information provided by bd represents all of 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.

• Brand Name: BARDEX ALL-SILICONE TEMPERATURE-SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11365888
• MDR Text Key: 233077733
• Report Number: 1018233-2021-00701
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046018
• UDI-Public: (01)00801741046018
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/10/2021

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
• Device Operator: Health Professional
• Device Model Number: 119112
• Device Catalogue Number: 119112
• Device Lot Number: NGEQ4214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/23/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other