BARDEX LUBRI-SIL I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER

Report

Report Number: 1018233-2021-00525
Event Type: Injury
Date Received: February 16, 2021
Date of Event: January 21, 2021
Report Date: July 20, 2021
Manufacturer: C.R. BARD, INC. (COVINGTON) -1018233
Product Code: MJC
PMA / PMN Number: K070582
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE REPORTED EVENT WAS UNCONFIRMED SINCE THE PROBLEM COULD NOT BE REPRODUCED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED SILICONE FOLEY WITH METER BAG, INLET TUBING AND SAMPLE PORT CONNECTOR. VISUAL INSPECTION OF THE SAMPLE NOTED NO OBVIOUS VISIBLE DEFECTS. THE CATHETER WAS FLUSHED WITH METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER) DID NOT LEAK. THE SOLUTION FLOWED INTO THE METER BAG EASILY WITHOUT RESISTANCE. THE SAMPLE PORT CONNECTOR AND INLET TUBING WAS ALSO FLUSHED AND DID NOT LEAK OR IMPEDE FLOW. THE CATHETER BALLOON WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND DID NOT LEAK. THE BALLOON RESTED FOR 30 MINUTES WITHOUT LEAKS AND PASSIVELY DEFLATED IN WITHOUT ISSUE OR CUFFING, RETURNING 10ML OF SOLUTION. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. THE DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THE REPORTED EVENT WAS UNCONFIRMED. LABELING REVIEW WAS NOT PERFORMED AS THE REPORTED EVENT WAS UNCONFIRMED. 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.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED IN THE EMERGENCY DEPARTMENT. IT WAS NOTED THAT THERE WAS NO URINE DRAINAGE FROM THE FOLEY CATHETER, AND THE PATIENT'S BLADDER SCAN WAS GREATER THAN 999 ML. THE CATHETER POSITION WAS VERIFIED WITH A SECOND NURSE. AN ATTEMPT WAS MADE TO FLUSH THE FOLEY, IT WAS UNSUCCESSFUL. THE FOLEY CATHETER WAS CHANGED OUT. IT WAS OBSERVED THAT THE PATIENT HAD 1.2 LITERS OF URINE OUTPUT. VISUAL INSPECTION OF THE REMOVED CATHETER SHOWED NOTHING WAS UNUSUAL, HOWEVER, AN ATTEMPT WAS MADE TO FLUSH THE PORT, AND IT WAS UNABLE TO FLUSH. PER ADDITIONAL INFORMATION RECEIVED ON 27JAN2021 FROM THE COMPLAINANT VIA EMAIL, THE URINARY RETENTION WAS RELIEVED WITH PLACEMENT OF THE SECOND CATHETER AND THE PATIENT REQUIRED NO ADDITIONAL INTERVENTION.

Additional Manufacturer Narrative · 1

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED IN THE EMERGENCY DEPARTMENT. IT WAS NOTED THAT THERE WAS NO URINE DRAINAGE FROM THE FOLEY CATHETER, AND THE PATIENT'S BLADDER SCAN WAS GREATER THAN 999 ML. THE CATHETER POSITION WAS VERIFIED WITH A SECOND NURSE. AN ATTEMPT WAS MADE TO FLUSH THE FOLEY, IT WAS UNSUCCESSFUL. THE FOLEY CATHETER WAS CHANGED OUT. IT WAS OBSERVED THAT THE PATIENT HAD 1.2 LITERS OF URINE OUTPUT. VISUAL INSPECTION OF THE REMOVED CATHETER SHOWED NOTHING WAS UNUSUAL, HOWEVER, AN ATTEMPT WAS MADE TO FLUSH THE PORT, AND IT WAS UNABLE TO FLUSH. PER ADDITIONAL INFORMATION RECEIVED ON 27JAN2021 FROM THE COMPLAINANT VIA EMAIL, THE URINARY RETENTION WAS RELIEVED WITH PLACEMENT OF THE SECOND CATHETER AND THE PATIENT REQUIRED NO ADDITIONAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
229472	BARDEX LUBRI-SIL I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER	FOLEY CATHETER	MJC	C.R. BARD, INC. (COVINGTON) -1018233		NGER1047

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Required Intervention