MAUDE Adverse Event Report: DEGANIA SILICONE LTD TEMPERATURE SENSING FOLEY CATHETER; SILICONE FOLEY CATHETER

Model Number 16 FRENCH

Device Problem Material Perforation (2205)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Two received catheters were inspected and we did not detect any production related defect.No non-conformities were detected during the batch history review of the possible batches.The balloons could fail due to user related reasons.The complaint considered to be not justified.No capa is required in this case.

Event Description

We recently received a complaint on our temperature sensing foley catheters bursting while in use with patients.Two samples were received and retained, one with a pin-sized hole and the other with a slit along the length of the balloon.

• Brand Name: TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer Contact: katia kayam ; degania bet; degania bet, jordan valley 15130-00 ; IS 1513000
• MDR Report Key: 10703038
• MDR Text Key: 212147379
• Report Number: 8030107-2020-00037
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K063442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2022
• Device Model Number: 16 FRENCH
• Device Catalogue Number: 102201101663MD
• Device Lot Number: V20011763
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2017
• 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