Brand Name | UNSPECIFIED BD Q-SYTE¿ LUER ACCESS SPLIT SEPTUM (STAND-ALONE DEVICE) |
Type of Device | INTRAVASCULAR ADMINISTRATION SET |
Manufacturer (Section D) |
BD MEDICAL, MEDICATION DELIVERY SOLUTIONS |
1 becton drive |
franklin lakes NJ 07417 |
|
Manufacturer (Section G) |
BD MEDICAL, MEDICATION DELIVERY SOLUTIONS |
1 becton drive |
|
franklin lakes NJ 07417 |
|
Manufacturer Contact |
helen
cox (mdr)
|
75 north fairway drive |
vernon hills, IL 60061
|
8473935694
|
|
MDR Report Key | 18026966 |
MDR Text Key | 326807115 |
Report Number | 2243072-2023-01959 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Study,User Facility |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
10/13/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/29/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | UNKNOWN |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/11/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |