NURSE ASSIST, LLC
Report
- Report Number
- 3002695476-2024-00047
- Event Type
- Injury
- Date Received
- July 25, 2024
- Report Date
- July 3, 2024
- Manufacturer
- NURSE ASSIST, LLC
- Product Code
- FRO
- PMA / PMN Number
- K083042
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
AN EMAIL WAS SENT TO PRODUCT REMOVE INFO EMAIL ADDRESS BY (B)(6) ON (B)(6) 2023. THE EMAIL WAS FORWARDED TO. THE COMPLAINTS DEPARTMENT ON (B)(6) 2024, WHICH INITIATED NURSE ASSIST'S INVESTIGATION OF THE REPORTED INCIDENT AND DETERMINATION THAT THE NOTED INCIDENT WAS REPORTABLE. A FOLLOW-UP EMAIL WAS SENT TO (B)(6) BY THE COMPLAINTS DEPARTMENT ON (B)(6) 2024. REQUESTING ADDITIONAL INFORMATION TO AID WITH REPORTING AND WITH THE INVESTIGATION. THE PRODUCT REMOVAL INFO EMAIL ADDRESS WAS INTENDED TO BE USED SOLELY FOR FACILITATING RETURN AND REPLACEMENT OF PRODUCT AND WAS NOT BEING REVIEWED FOR COMPLAINT INFORMATION, WHICH RESULTED IN THE DELAY OF REPORTING THIS INCIDENT. THE PRODUCT REMOVAL. INFO EMAIL INBOX IS BEING EXPEDITIOUSLY REVIEWED TO IDENTIFY ANY OTHER INCIDENT RELATED INFORMATION THAT WOULD BE CONSIDERED AS A COMPLAINT.
COMMENTS INCLUDED IN EMAIL RECEIVED FROM COMPLAINTS: I HAVE SEVERAL ORDERS FROM AMAZON FOR THE STERILE 0.9% SALINE SOLUTION - 1000ML, AND I NEED TO KNOW WHAT TO DO. I HAVE EIGHT ORDERS; 7 HAVE BEEN USED, AND THE 8TH IS PARTIALLY USED. I DID END UP WITH A MASSIVE BLOOD INFECTION WITHIN MY PICC IV LINE AFTER USING THE STERILE SALINE. THE SELLERS ON AMAZON ARE: "(B)(4) ," "PREFERRED PHARMACY PLUS," AND "VANGUARD." WHAT DO I NEED TO DO NEXT?
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 534130 | NURSE ASSIST, LLC | 0.9% NORMAL SALINE FOR IRRIGATION USP IN SCREW TOP | FRO | NURSE ASSIST, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |