FDA Adverse Event
Malfunction
Summary report: N
ACCESS
MDR report key: 5262203
·
Received December 2, 2015
Report
- Report Number
- 1416980-2015-43224
- Event Type
- Malfunction
- Date Received
- December 2, 2015
- Date of Event
- November 4, 2015
- Report Date
- December 15, 2015
- Manufacturer
- BAXTER HEALTHCARE
- Product Code
- FPA
- PMA / PMN Number
- K961225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
(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 "MALE END" OF A CLEARLINK CONTINU-FLO SOLUTION SET 삒OKE OFF IN THE FEMALE LUER CONNECTION OF THE IV EXTENSION/LOCK TUBING." THIS OCCURRED DURING INFUSION OF INSULIN. THE REPORTER STATED THAT THE SET, "SALINE LOCK," AND INSULIN BAG WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO 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 |
|---|---|---|---|---|---|---|---|
| 791708 | ACCESS | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BAXTER HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |