MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-19 for BARD? TWO PIN PLUG, MONITOR CABLE 153625H manufactured by C.r. Bard, Inc. (covington) -1018233.
[186172894]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[186172895]
It was reported that while using the cord extension for temp sense catheter, the body temperature of the patient was not displayed on the monitor. Per additional information from the ibc via email 26feb2020, it was unknown if the temp sensing catheter or monitor were working correctly after the cable was changed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01930 |
| MDR Report Key | 9853385 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? TWO PIN PLUG, MONITOR CABLE |
| Generic Name | 2 PIN ROUND PLUG EXTENSION CORD FOR TEMP SENSE CATH |
| Product Code | EZL |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-02-27 |
| Model Number | 153625H |
| Catalog Number | 153625H |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |