Type of Device | SYRINGE/NDL, SAFETY 1CC 23GX1" |
Manufacturer (Section D) |
GUANGDONG HAIOU MEDICAL APPARATUS CO., LTD |
nanyuan industrial zone |
north liusha |
punning city, guangdong 51530 0 |
CH 515300 |
|
Manufacturer (Section G) |
MCKESSON MEDICAL SURGICAL, INC. |
1125 sycamore road |
|
manteno IL 60950 |
|
Manufacturer Contact |
jo
silverthorne
|
9954 mayland drive |
richmond, VA 23233
|
8045532278
|
|
MDR Report Key | 11633968 |
MDR Text Key | 250228367 |
Report Number | 3017368639-2021-00021 |
Device Sequence Number | 1 |
Product Code |
MEG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | 141349 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
04/08/2021 |
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 Operator |
Health Professional
|
Device Catalogue Number | NRSS1-23G25 |
Device Lot Number | 20JC2 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/26/2021
|
Initial Date FDA Received | 04/08/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/18/2020 |
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 |
Patient Outcome(s) |
Other;
|
|
|