SUCTION TUBE MCEN770B30 BLUNT TIP
Report
- Report Number
- 3003249645-2024-00032
- Event Type
- Malfunction
- Date Received
- June 26, 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
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 FOUND THAT THE STEM OF THE SUCTION TUBE 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 WAS SUBSEQUENTLY REPORTED THAT THE NUMBER OF USES FOR THIS INSTRUMENT IS UNKNOWN AND CANNOT BE ESTIMATED.
THIS REPORT IS 5 OF 10 AND IS RELATED TO MFG REPORT NUMBERS: 3003249645-2024-00029, 3003249645-2024-00028, 3003249645-2024-00031, 3003249645-2024-00030, 3003249645-2024-00033, 3003249645-2024-00034, 3003249645-2024-00035, 3003249645-2024-00036 AND 3003249645-2024-00037. IT WAS REPORTED THAT 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 |
|---|---|---|---|---|---|---|---|
| 2102210 | SUCTION TUBE MCEN770B30 BLUNT TIP | PFM11 | JZF | INTEGRA MICROFRANCE S.A.S. | 3673577 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |