MAUDE Adverse Event Report: DEGANIA SILICONE LTD MON-A-THERM¿ FOLEY CATHETERS WITH TEMPERATURE SENSORS; 2W SIL.FOLEY CATH 14FR W/TEMP.SENSOR

Model Number 14FR

Device Problem Incorrect Measurement (1383)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Incorrect temperature reading was caused by defective sensors, which are purchased component.Degania silicone purchased and assembled the sensors into its silicon catheter.The supplier of the sensors had production issue which was not caught in timely manner.The issue was related to sensor tip grinding operation, improperly performed by newly hired operators.The estimated failure rate is 3-4% of total quantity of suspected sensor lots.It was explained by the supplier of the sensors, that the cracks in defective thermistor tip did not appear immediately but developed following impact of different factors like time, transportation conditions, humidity.This is the reason the in-process degania tests did not detect the problem.Planned and completed corrective actions of the supplier: re-training of the operators for correct performance of grinding operation (completed (b)(6) 2017); improved control of grinding quality by line leaders and qc staff (completed on (b)(6) 2017); gauge r&r testing of all involved personnel (completed on (b)(6) 2017); improved visual aids are put on working stations (completed (b)(6) 2017); the effectiveness of the above actions was verified during the visit of degania team to the supplier facility on 20-23 of august 2018.It is notable that the lots in finished goods manufactured with the most recently manufactured sensors (sensor lots 429455 and 431101), manufactured on april 27th and april 24th 2017, respectively) had no failures for temperature deviations (out of a total of 39 samples tested).This further substantiates the bracketing of january through april of 2017.The qc testing at the sensor manufacture from may 2017 through august of 2018 was reviewed and showed no chips with sharp points.The data confirm that the bracketed period is appropriate and the likelihood of a temperature deviation outside of the bracketed period is remote.Preventive actions of degania: update of aql sampling level during incoming inspection of sensors completed (b)(6) 2018.The current 100% room temp testing procedure will be improved to prevent influence of room temperature variations on measurement results completed (b)(6) 2018.

Event Description

Temp.Reading not ok.Catheter showed temperature of 34c while the under-tongue probe gave 37c.

• Brand Name: MON-A-THERM¿ FOLEY CATHETERS WITH TEMPERATURE SENSORS
• Type of Device: 2W SIL.FOLEY CATH 14FR W/TEMP.SENSOR
• 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: 9375690
• MDR Text Key: 205493283
• Report Number: 8030107-2019-00023
• Device Sequence Number: 1
• Product Code: EYB
• 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,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14FR
• Device Catalogue Number: 102201101463BI
• Device Lot Number: V17011659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: RES 80641
• Patient Sequence Number: 1
• Patient Outcome(s): Other