SUCTION TUBE MCEN770B30 BLUNT TIP
Report
- Report Number
- 3003249645-2024-00037
- Event Type
- Malfunction
- Date Received
- June 27, 2024
- Report Date
- August 21, 2024
- Manufacturer
- INTEGRA MICROFRANCE S.A.S.
- Product Code
- JZF
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE BLUNT TIP SUCTION TUBE (MCEN770B30) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: EVALUATION OF THE SUCTION TUBE FOUND THAT THE STEM WAS BROKEN AT THE BASE OF THE HANDLE AT THE WELD. ROOT CAUSE ANALYSIS: IT WAS DETERMINED THAT AN ERROR IN THE HANDLING OF THE INSTRUMENT BY THE CUSTOMER, AN EXCESSIVE FORCE WAS APPLIED LEADING TO STEM BREAKAGE. IT IS NOTED THAT THE DEVICE IS 19 YEARS OLD.
IT WAS REPORTED THAT THE NUMBER OF USES FOR THIS INSTRUMENT IS UNKNOWN AND COULD NOT BE ESTIMATED. IT IS NOTED THAT THIS INSTRUMENT WAS MANUFACTURED 19 YEARS AGO.
THIS REPORT IS 10 OF 10 AND IS RELATED TO MFG REPORT NUMBERS: 3003249645-2024-00029; 3003249645-2024-00028; 3003249645-2024-00031; 3003249645-2024-00030; 3003249645-2024-00032; 3003249645-2024-00033; 3003249645-2024-00034; 3003249645-2024-00035; 3003249645-2024-00036. IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE WELDING OF THE BLUNT TIP SUCTION TUBE (MCEN770B30) BROKE BETWEEN THE HANDLE AND STEM. ANOTHER DEVICE WAS AVAILABLE FOR USE. NO INFORMATION ON PATIENT IMPACT IS AVAILABLE AT THIS TIME.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1722945 | SUCTION TUBE MCEN770B30 BLUNT TIP | PFM11 | JZF | INTEGRA MICROFRANCE S.A.S. | 04-05 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |