FDA Adverse Event
Injury
Summary report: N
MALLINKCRODT
MDR report key: 1858756
·
Received September 30, 2010
Report
- Report Number
- 2936999-2010-01233
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- BTS
- PMA / PMN Number
- K771219
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). APPLICABLE 510K # FOR U.S. DISTRIBUTED PART IS K771219. THE SAMPLE ASSOCIATED TO THIS REPORT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE CUSTOMER DID PROVIDE A LOT #. MANUFACTURING WILL PERFORM A LOT HISTORY REVIEW OF THE REPORTED LOT AS PART OF THE INVESTIGATION. IF SIGNIFICANT INFORMATION IS IDENTIFIED FROM THE LOT REVIEW THEN A SUMMARY OF FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE TUBE RIPPED AT THE CUFF DURING PATIENT USE. EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. REF MFR # 2936999-2010-01235.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALLINKCRODT | BRONCHO-CATH ENDOBRONCHIAL TUBE | BTS | COVIDIEN, FORMERLY TYCOHEALTHCARE | 2010017085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |