MEDTRONIC EXTENDED
Report
- Report Number
- 8021545-2024-01518
- Event Type
- Malfunction
- Date Received
- June 26, 2024
- Date of Event
- May 17, 2024
- Report Date
- December 17, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244023314
- PMA / PMN Number
- K210544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
E1: (B)(6).
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY CAPA-2010953 "TREND OBSERVED: INCREASE IN COMPLAINTS RELATED TO ADHESIVE ON EWIS" HAS BEEN OPENED ON 18-SEP-2024 TO ADDRESS ALL ADHESIVE ISSUES RELATED TO EWIS PRODUCT FAMILY AS NO SPECIFICATIONS EXIST FOR THE ADHESIVE USED ON THIS PRODUCT (DESIGN RELATED CAPA).
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES, ON 17-MAY-2024, IT WAS REPORTED THAT THE ONE INFUSION SET WAS FELLING OFF. NO FURTHER INFORMATION AVAILABLE.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1806735 | MEDTRONIC EXTENDED | UNO EWIS BLUE 80/9 HCAP 3-PK INT | FPA | UNOMEDICAL A/S | MMT-442AH | 6004295 | 05705244023314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |