FDA Adverse Event
Other
Summary report: N
CADD TUBING
MDR report key: 16910390
·
Received May 10, 2023
Report
- Report Number
- MW5117439
- Event Type
- Other
- Date Received
- May 10, 2023
- Report Date
- May 10, 2023
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- FPA
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- Health Professional
- *
Narratives
Description of Event or Problem · 0
CADD TUBING 7361 (LOT 4321084) PATIENT REPORTS THAT TUBING POPS OFF OF THE CONNECTING CAP TO THE PORT DURING INFUSION. HAPPENED WITH 2 TUBING SETS FROM THIS LOT NUMBER. PATIENT CLAMPED CATHETER AND REMOVED REMAINING CAP. STOPPED PUMP AND PROCEEDED TO DISCONNECT. ERROR REACHED PATIENT; NO PATIENT HARM. (B)(6). SUBMISSION ID: (B)(4). REFERENCE REPORT: MW5117440.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1164977 | CADD TUBING | SET, ADMINISTRATION, INTRAVASCULAR | FPA | SMITHS MEDICAL ASD, INC. | 21-7361-24 | 4321084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |