Brand Name | SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL |
Type of Device | SALINE, VASCULAR ACCESS FLUSH |
Manufacturer (Section D) |
BECTON DICKINSON |
1 becton drive |
franklin lakes NJ 07417 |
|
Manufacturer (Section G) |
BD MEDICAL (BD WEST) MEDICAL SURGICAL |
1852 10th avenue |
|
columbus NE 68601 |
|
Manufacturer Contact |
helen
cox (mdr)
|
75 north fairway drive |
vernon hills, IL 60061
|
8473935694
|
|
MDR Report Key | 18884755 |
MDR Text Key | 337762434 |
Report Number | 1911916-2024-00177 |
Device Sequence Number | 1 |
Product Code |
NGT
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K003553 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/08/2024 |
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 Operator |
Health Professional
|
Device Catalogue Number | 306547 |
Device Lot Number | UNKNOWN |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/27/2024
|
Initial Date FDA Received | 03/12/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |