COVIDIEN
Report
- Report Number
- 1423537-2024-00064
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Date of Event
- May 2, 2023
- Report Date
- August 9, 2024
- Manufacturer
- CARDINAL HEALTH, INC.
- Product Code
- KNT
- UDI-DI
- 10884521661714
- PMA / PMN Number
- K180622
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
PMA/510(K)NUMBER TO K180622. DEVICE MANUFACTURER DATE TO 14-DEC-2022. LABELED FOR SINGLE USE? TO YES. A PHOTO SAMPLE WAS RECEIVED FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL EVALUATION OF THE PHOTO SAMPLE, THE REPORTED WAS CONFIRMED; A RUPTURED BALLOON WAS CONFIRMED. THE ROOT CAUSE AND ACTION PLAN WILL BE DOCUMENTED THROUGH A FORMAL CORRECTIVE/PREVENTATIVE ACTION WHICH HAS BEEN INITIATED TO ADDRESS THE REPORTED CONDITION TO MITIGATE ANY FURTHER OCCURRENCES. CORRECTED: BRAND NAME FROM: GSTRO FEED TBE W/Y PRT 24FR TO: COVIDIEN. MANUFACTURER NAME TO FROM: CARDINAL HEALTH TO: CARDINAL HEALTH, INC. MODEL NUMBER/CATALOG NUMBER FROM: 8884720247 TO: 8884720205E. UNIQUE IDENTIFIER (UDI) # (B)(4).
UPDATED SECTION G3 / G4 DATE RECEIVED BY MANUFACTURER FROM "10-JUN-2023" TO "10-JUN-2024".
THE CUSTOMER REPORTED THAT THE BALLOON OF THE TUBE RUPTURED 4 WEEKS AFTER PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED, THE TUBE HAD TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2302343 | COVIDIEN | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | CARDINAL HEALTH, INC. | 8884720205E | 2324408164 | 10884521661714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |