SUCTION TUBE MCEN770B30 BLUNT TIP
Report
- Report Number
- 3003249645-2024-00036
- 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
- PHARMACIST
- Health Professional
- Yes
Narratives
HE 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 UNSOLDERED FROM THE HANDLE. ROOT CAUSE ANALYSIS: IT WAS DETERMINED THAT THIS PROBLEM WAS DUE TO POOR WELD FINISHING DURING MANUFACTURING OPERATIONS.
IT WAS REPORTED THAT THE NUMBER OF USES FOR THIS INSTRUMENT IS UNKNOWN AND CANNOT BE ESTIMATED. AN AWARENESS TRAINING HAS BEEN PROVIDED TO THE OPERATORS TO RE-ENFORCE GOOD WELDING PRACTICES.
THIS REPORT IS 9 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 AND 3003249645-2024-00037. 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 |
|---|---|---|---|---|---|---|---|
| 1722946 | SUCTION TUBE MCEN770B30 BLUNT TIP | PFM11 | JZF | INTEGRA MICROFRANCE S.A.S. | 7118292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |