YPSOPUMP® INSET
Report
- Report Number
- 3003442380-2024-28227
- Event Type
- Malfunction
- Date Received
- October 14, 2024
- Date of Event
- September 15, 2024
- Report Date
- November 13, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D9: DEVICE AVAILABLE FOR EVALUATION HAS BEEN SELECTED AS YES & DATE RETURNED TO MFG WAS ADDED AS WELL. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY. THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6004043 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR. COMPLAINT INVESTIGATIONS. PHOTO WAS PROVIDED AND THERE IS VISIBLE DEFECT (THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR) ON THE RECEIVED PHOTO. THEREFORE, AN INSPECTION TO THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION ACCORDING TO WITH WI VERSION 39 & WI VERSION 18, TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 (STATIC PULL TEST) ACCORDING TO WITH WI VERSION 46, TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 (CLICK TEST) ACCORDING TO WITH WI VERSION 39 VERSION 18, TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6004043 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 66 ON THE PACKING PROCESS ON THE PACKING PROCESS IN THE LINE L171, ON 27/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECTS OR DAMAGES ON THE RETURNED SAMPLES, NO REPORTED HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. AND THERE IS A VISIBLE DEFECT ON RECEIVED PHOTO.
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. THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6004043 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE). COMPLAINT INVESTIGATIONS. PHOTO WAS PROVIDED AND THERE IS VISIBLE DEFECT (THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR) ON THE RECEIVED PHOTO. THEREFORE, AN INSPECTION TO THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION ACCORDING TO WITH WI VERSION 39 & WI VERSION 18 , TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 (STATIC PULL TEST) ACCORDING TO WITH WI VERSION 46, TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 (CLICK TEST) ACCORDING TO WITH WI VERSION 39 VERSION 18 , TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6004043 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 66 ON THE PACKING PROCESS ON THE PACKING PROCESS IN THE LINE L171, ON 27/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECTS OR DAMAGES ON THE RETURNED SAMPLES, NO REPORTED HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. AND THERE IS A VISIBLE DEFECT ON RECEIVED PHOTO.
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: THE COMPLAINT (B)(4) HAS BEEN EVALUATED. THE LOT 6004043 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTIONS (WI) GUIDELINE FOR TEST OF REFERENCE. SAMPLES VERSION 11 FOR THE CODE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE). COMPLAINT INVESTIGATIONS. PHOTO WAS PROVIDED AND THERE IS VISIBLE DEFECT (THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR) ON THE RECEIVED PHOTO. THEREFORE, AN INSPECTION TO THE REFERENCE SAMPLES FROM THE LOT HAS BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL INSPECTION ACCORDING TO WITH WI VERSION 39 & WI VERSION 18 , TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 (STATIC PULL TEST) ACCORDING TO WITH WI VERSION 46, TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 2 (CLICK TEST) ACCORDING TO WITH WI VERSION 39 VERSION 18 , TEST ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: THE LOT 6004043 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 66 ON THE PACKING PROCESS ON THE PACKING PROCESS IN THE LINE L171, ON 27/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. CONCLUSION SUMMARY OF THE RELATED EVENT. AS A RESULT OF THE FOLLOWING: NO DEFECTS OR DAMAGES ON THE RETURNED SAMPLES, NO REPORTED HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION. AND THERE IS A VISIBLE DEFECT ON RECEIVED PHOTO.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT WHERE THE TUBING WAS PULLING AWAY FROM THE CANNULA. PATIENT HAD BEEN A LONG TIME USER OF THE INSET AND WAS CONFIDENT SHE WAS NOT PULLING AT THEM. NO FURTHER INFORMATION AVAILABLE.
TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.
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 |
|---|---|---|---|---|---|---|---|
| 1874309 | YPSOPUMP® INSET | UNO INSET II 80/6 GREY Y-CAP 10PAK INT | FPA | UNOMEDICAL A/S | 86-080-52B6 | 6004043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |