N
Patient 1
(B)(4).
MAUDE MDR 9323320
- MDR report key
- 9323320
- Report number
- 3003898360-2019-01370
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-01
- Date received
- 2019-11-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- VICTORIA SANDLIN
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HUDSON ET TUBE, SHER-I-BRONCH, LS, 37 FR | TUBE, TRACHEAL/BRONCHIAL, DIFF | TELEFLEX MEDICAL | CBI | 5-16037 | 73G1800931 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-14 | 0 |
Event Narratives#
D
Patient 1
CUSTOMER REPORTED UPON OPENING PACKAGE THE "CONNECTION OF ANGLE CONNECTOR" WAS FOUND BROKEN OFF. ISSUE DETECTED PRIOR TO USE. NO PATIENT INVOLVEMENT REPORTED.
N
Patient 1
QN# (B)(4). THE CUSTOMER RETURNED ONE UNIT 5-16037 ET TUBE, SHER-I-BRONCH, LS, 37 FR FOR INVESTIGATION. THE SHER-I-BRONCH TUBE AND TWO SUCTION CATHETERS WERE RETURNED UNOPENED IN THEIR ORIGINAL PACKAGING. THE DOUBLE SWIVEL VALVE ASSEMBLY (TRACHEAL/BRONCHIAL SWIVEL VALVES) AND THE Y CONNECTOR WERE ALSO RETURNED WITH THE PACKAGING. THE RETURNED SAMPLE WAS VISUALLY EXAMINED WITH AND WITHOUT MAGNIFICATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED THAT THE CONNECTOR ON THE BRONCHIAL SIDE OF THE SWIVEL VALVE WAS BROKEN. THE SWIVEL VALVE IS A COMPONENT PURCHASED FROM A SUPPLIER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORTED COMPLAINT OF "ANGLE CONNECTOR BROKE OFF" WAS CONFIRMED BASED ON THE SAMPLE RECEIVED. THE CONNECTOR ON THE BRONCHIAL SIDE OF THE SWIVEL VALVE WAS BROKEN. THE SWIVEL VALVE IS A COMPONENT PURCHASED FROM A SUPPLIER. A NON-CONFORMANCE HAS BEEN OPENED TO FURTHER INVESTIGATE THIS ISSUE.
D
Patient 1
CUSTOMER REPORTED UPON OPENING PACKAGE THE "CONNECTION OF ANGLE CONNECTOR" WAS FOUND BROKEN OFF. ISSUE DETECTED PRIOR TO USE. NO PATIENT INVOLVEMENT REPORTED.