Brand Name | HUDSON VENTILATOR TUBING SET,LONG LENGTH |
Type of Device | CIRCUIT, BREATHING (W CONNECTO |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
parque industrial finsa |
|
nuevo laredo 88275 |
MX
88275
|
|
Manufacturer Contact |
marling
heaton
|
3015 carrington mill blvd |
morrisville 27560
|
|
MDR Report Key | 12921104 |
MDR Text Key | 283158323 |
Report Number | 3004365956-2021-00312 |
Device Sequence Number | 1 |
Product Code |
CAI
|
UDI-Device Identifier | 14026704658920 |
UDI-Public | 14026704658920 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/09/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | IPN913687 |
Device Catalogue Number | 1613 |
Device Lot Number | 74D2001235 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/09/2021 |
Initial Date FDA Received | 12/02/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/10/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |