FDA Adverse Event
Malfunction
Summary report: N
SHER-I-BRONCH LS ET TUBE 35 FR
MDR report key: 2181193
·
Received July 7, 2011
Report
- Report Number
- 3003898360-2011-00293
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- June 25, 2011
- Report Date
- June 27, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BTR
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE OR LOT # WAS RETURNED FOR INVESTIGATION. EVALUATION: CONCLUSIONS: NO EVALUATION WILL BE PERFORMED. NO CONCLUSION CAN BE DRAWN. NO ROOT CAUSE COULD BE DETERMINED. NO CORRECTIVE ACTIONS TAKEN.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT THE BRONCHIAL SIDE OF THE TUBE COLLAPSED DURING A PROCEDURE AND THE LEFT LUNG COULD NOT BE DEFLATED. SINCE THE CHEST WAS ALREADY OPENED, THE CASE HAD TO BE COMPLETED WITH THE LEFT LUNG INFLATED. THE PT'S CONDITION IS REPORTED AS BEING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHER-I-BRONCH LS ET TUBE 35 FR | ENDOTRACHEAL TUBE | BTR | TELEFLEX MEDICAL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |