UNKNOWN LATEX TEMP-SENSING CATHETER
Report
- Report Number
- 1018233-2025-03821
- Event Type
- Injury
- Date Received
- May 23, 2025
- Date of Event
- April 21, 2025
- Report Date
- June 13, 2025
- Manufacturer
- C.R. BARD, INC. (COVINGTON) -1018233
- Product Code
- EZC
- PMA / PMN Number
- K910846
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. NO ACTIONS CAN BE TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.
IT WAS REPORTED THAT REGISTERED NURSE CAME INTO ROOM TO GIVE PATIENT MEDICATIONS. PATIENT COMPLAINING OF SUDDEN SHARP PAIN AT UNKNOWN LATEX TEMPERATURE SENSING CATHETER INSERTION SITE AFTER ASSESSED PATIENT, REGISTERED NURSE FOUND FOLEY NEXT TO PATIENT WITH BALLOON NOT INTACT. PAIN MEDICATION GIVEN TO PATIENT AND PHYSICIAN NOTIFIED. PATIENT IS A 29-YR FEMALE ADMITTED IN 2025 AS A TRAUMA ALERT STATUS POST BEEN STRUCK BY A VEHICLE WHILE ON A MOPED. THIS IS REPORTED AS THE THIRD TEMP SENSING FOLEY BALLOON THAT HAD RUPTURED IN A PATIENT RECEIVING GENTAMYCIN IRRIGATION. SEE NOTES FOR ADDITIONAL INFORMATION REGARDING COMPATIBILITY BETWEEN FOLEY AND GENTAMYCIN SOLUTION. CONFIRMED THAT GENTAMYCIN IRRIGATION SOLUTION WAS PREPARED IN LUER LOCK SYRINGE AND PLACED THROUGH THE PORT LOCATED AT THE TOP OF THE DRAINAGE TUBING. SEVERITY OF EVENT, EVENT REACHED PATIENT AND NO HARM OR NO DETECTABLE HARM.
IT WAS REPORTED THAT REGISTERED NURSE CAME INTO ROOM TO GIVE PATIENT MEDICATIONS. PATIENT COMPLAINING OF SUDDEN SHARP PAIN AT UNKNOWN LATEX TEMPERATURE SENSING CATHETER INSERTION SITE AFTER ASSESSED PATIENT, REGISTERED NURSE FOUND FOLEY NEXT TO PATIENT WITH BALLOON NOT INTACT. PAIN MEDICATION GIVEN TO PATIENT AND PHYSICIAN NOTIFIED. PATIENT IS A 29-YR FEMALE ADMITTED IN 2025 AS A TRAUMA ALERT STATUS POST BEEN STRUCK BY A VEHICLE WHILE ON A MOPED. THIS IS REPORTED AS THE THIRD TEMP SENSING FOLEY BALLOON THAT HAD RUPTURED IN A PATIENT RECEIVING GENTAMYCIN IRRIGATION. SEE NOTES FOR ADDITIONAL INFORMATION REGARDING COMPATIBILITY BETWEEN FOLEY AND GENTAMYCIN SOLUTION. CONFIRMED THAT GENTAMYCIN IRRIGATION SOLUTION WAS PREPARED IN LUER LOCK SYRINGE AND PLACED THROUGH THE PORT LOCATED AT THE TOP OF THE DRAINAGE TUBING. SEVERITY OF EVENT, EVENT REACHED PATIENT AND NO HARM OR NO DETECTABLE HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1069905 | UNKNOWN LATEX TEMP-SENSING CATHETER | UNKNOWN TEMPERATURE SENSING FOLEY CATHETER | EZC | C.R. BARD, INC. (COVINGTON) -1018233 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR | Female | Required Intervention |