8FR REPLOGLE SUCT CATH
Report
- Report Number
- 9612030-2022-03221
- Event Type
- Malfunction
- Date Received
- April 15, 2022
- Report Date
- May 6, 2022
- Manufacturer
- CARDINAL HEALTH
- Product Code
- KDH
- UDI-DI
- 10884521000711
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCY WAS FOUND ACCORDING TO THE REPORTED CONDITION. THERE WERE NO SAMPLES OR PHOTOGRAPHS SUBMITTED FOR REVIEW AND INVESTIGATION. BASED ON THE LIMITED INFORMATION RECEIVED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED NOR RELATED TO A MANUFACTURING PROCESS. ALL ASSOCIATED LOT DOCUMENTATION WAS CAREFULLY REVIEWED WITH NO ISSUES OR DISCREPANCIES WERE FOUND RELATED TO THE REPORTED COMPLAINT. BASED ON THE ANALYSIS, THE OBSERVED OCCURRENCE OF HARM IMPROBABLE WHICH IS BELOW THE RANGE OF THE EXPECTED OCCURRENCE RATE THEREFORE CORRECTIVE ACTIONS ARE NOT DEEMED NECESSARY AT THIS TIME.
CUSTOMER REPORTS: THERE IS AN ISSUE WITH THE REPLOGLE SUCTION CATHETER. THE NURSING STAFF TRIED ONE THIS MORNING AND IT WAS DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 4/14/22 STATING THAT THE REPLOGLE WAS FOUND OCCLUDED; IT WOULD NOT ASPIRATE OR FLUSH WITH AIR. THE DEVICE WAS REPLACED AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 167155 | 8FR REPLOGLE SUCT CATH | CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION | KDH | CARDINAL HEALTH | 8888256529 | 2126437964 | 10884521000711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |