MAUDE Adverse Event Report: DEGANIA MEDICAL DEVICES PVT. LTD FOLEY CATHETER WITH TEMPERATURE SENSOR; TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER

Model Number 16 FRENCH

Device Problems Complete Blockage (1094); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that two catheters were blocked and did not conduct urine.We checked the batch history records and no non conformities were detected.The retain samples from the same batch was tested and it functioned properly, no blockage was detected.We are expecting to receive and evaluate the actual sample.Additional report will be submitted.

Event Description

After we opened the package (for use), we found that the catheters were blocked and did not conduct urine.There were 2 occupancies within 1 month.

Manufacturer Narrative

The customer reported that two catheters were blocked and did not conduct urine.We checked the batch history records and no non conformites were detected.The retain samples from the same batch was tested and it functioned properly, no blockage was detected.We are expecting to receive and evaluate the actual sample.Additional report will be submitted.Update of 07/29/2020: we evaluated the actual device and detected that there is partial blockage of the drainage lumen of the catheter by excessive silicone material, which happened during injection process (injection of funnel upon a shaft).As a corrective action, it was decided to implement 100% inspection of catheters by pin after funnel injection molding stage, in order to ensure detection of partially blocked parts.

Event Description

After we opened the package (for use), we found that the catheters were blocked and did not conduct urine.There were 2 occupancies within 1 month.

• Brand Name: FOLEY CATHETER WITH TEMPERATURE SENSOR
• Type of Device: TEMPERATURE SENSING 100% SILICONE FOLEY CATHETER
• Manufacturer (Section D): DEGANIA MEDICAL DEVICES PVT. LTD; plot no. 251, sector-6,; imt manesar; gurgaon, india 12205 0; IN 122050
• MDR Report Key: 10126601
• MDR Text Key: 202218742
• Report Number: 3005483737-2020-00003
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K063442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/07/2020

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 Expiration Date: 01/28/2024
• Device Model Number: 16 FRENCH
• Device Catalogue Number: 102205101680AB
• Device Lot Number: S19001253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/07/2020
• Supplement Dates Manufacturer Received: 05/11/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1