BARD® EXTENSION CABLE
Report
- Report Number
- 1018233-2023-03013
- Event Type
- Malfunction
- Date Received
- April 28, 2023
- Date of Event
- April 6, 2023
- Report Date
- July 5, 2023
- Manufacturer
- C.R. BARD INC. (COVINGTON) -1018233
- Product Code
- EZL
- UDI-DI
- 00801741045875
- PMA / PMN Number
- K070582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE REPORTED EVENT IS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED FOR EVALUATION AND FURTHER INVESTIGATION WAS NOT CONCLUSIVE. THOUGH A SPECIFIC CAUSE CANNOT BE DETERMINED, POTENTIAL ROOT CAUSES FOR THIS FAILURE ARE "WRONG DIMENSIONS ON COMPETITORS OR OUR OWN CONNECTOR" OR "USER DAMAGED PINS WHEN INSERTING CONNECTOR". THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: " FOR USE WITH BARD TEMPERATURE-SENSING PRODUCTS AND ACCESSORIES". 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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. H3: THE DEVICE WAS NOT RETURNED.
IT WAS REPORTED THAT TEMPERATURE WAS NOT PROPERLY DISPLAYED ON MONITOR. WHEN CONNECTING THE 153622 CABLE TO MEASURE THE TEMPERATURE, THE MONITOR DID NOT DISPLAY THE TEMPERATURE. WHEN THE CUSTOMER TRIED AGAIN LATER, IT WAS DISPLAYED, BUT WHEN THEY SLIGHTLY TOUCHED THE CONNECTION BETWEEN THE CATHETER AND THE 153622 CABLE DURING THE DISPLAY, THE TEMPERATURE DISPLAY DISAPPEARED AND THEN REAPPEARED. AS PER THE ADDITIONAL INFORMATION RECEIVED VIA IBC ON 12APR2023, IT WAS REPORTED THAT WHEN THE USER SLIGHTLY TOUCHED THE CONNECTION BETWEEN THE CATHETER AND THE 153622 CABLE DURING THE DISPLAY, THE TEMPERATURE DISPLAY DISAPPEARED AND THEN REAPPEARED. ACCORDING TO THIS STATEMENT, THE FITTING ISSUE BETWEEN THE CATHETER AND THE 153622 CABLE MIGHT HAVE CAUSED THE ERRATIC DISPLAY. HOWEVER, SINCE THE SAMPLE IS NOT AVAILABLE, WE CANNOT CONFIRM WHETHER IT WAS A FITTING ISSUE.
IT WAS REPORTED THAT TEMPERATURE WAS NOT PROPERLY DISPLAYED ON MONITOR. WHEN CONNECTING THE 153622 CABLE TO MEASURE THE TEMPERATURE, THE MONITOR DID NOT DISPLAY THE TEMPERATURE. WHEN THE CUSTOMER TRIED AGAIN LATER, IT WAS DISPLAYED, BUT WHEN THEY SLIGHTLY TOUCHED THE CONNECTION BETWEEN THE CATHETER AND THE 153622 CABLE DURING THE DISPLAY, THE TEMPERATURE DISPLAY DISAPPEARED AND THEN REAPPEARED. AS PER THE ADDITIONAL INFORMATION RECEIVED VIA IBC ON 12APR2023, IT WAS REPORTED THAT WHEN THE USER SLIGHTLY TOUCHED THE CONNECTION BETWEEN THE CATHETER AND THE 153622 CABLE DURING THE DISPLAY, THE TEMPERATURE DISPLAY DISAPPEARED AND THEN REAPPEARED. ACCORDING TO THIS STATEMENT, THE FITTING ISSUE BETWEEN THE CATHETER AND THE 153622 CABLE MIGHT HAVE CAUSED THE ERRATIC DISPLAY. HOWEVER, SINCE THE SAMPLE IS NOT AVAILABLE, WE CANNOT CONFIRM WHETHER IT WAS A FITTING ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1417589 | BARD® EXTENSION CABLE | EXTENSION CABLE | EZL | C.R. BARD INC. (COVINGTON) -1018233 | 153622 | UNK | 00801741045875 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |