FDA Adverse Event
Malfunction
Summary report: N
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
MDR report key: 8704260
·
Received June 17, 2019
Report
- Report Number
- 1416980-2019-03306
- Event Type
- Malfunction
- Date Received
- June 17, 2019
- Report Date
- June 17, 2019
- Manufacturer
- BAXTER HEALTHCARE - DOMINICAN REPUBLIC
- Product Code
- FPA
- PMA / PMN Number
- K961225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2019. THE CUSTOMER REPORTED THIS EVENT TO THE FDA THROUGH MEDWATCH (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NURSE DISCONNECTED THE TUBING OF A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET FROM A NON-BAXTER CLEAR CAP AND THE TIP OF THE TUBING BROKE OFF; IT REMAINED IN THE CAP. THE CAP WAS CHANGED. THIS EVENT OCCURRED DURING AND UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 498866 | CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE - DOMINICAN REPUBLIC | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |