AUTOSOFT XC
Report
- Report Number
- 3003442380-2025-05988
- Event Type
- Injury
- Date Received
- April 10, 2025
- Date of Event
- January 10, 2024
- Report Date
- October 23, 2025
- Manufacturer
- UNOMEDICAL UM-D
- Product Code
- FPA
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL AND FINAL MDR (B)(4). DEVICE 1 OF 6.
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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6010318, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010318 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 20 AND PACKAGING IN THE MACHINE MULTIVAC 14 ON 28-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 4L02427 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 15 AND MANUFACTURED IN THE MACHINE LC01, ON 27-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING TUBE OF THE LOT 4L01183 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 15 AND MANUFACTURED IN THE MACHINE LC01, ON 17-NOV-2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.
SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2025-05988. AN INITIAL MEDICAL DEVICE REPORT (MDR) WAS SUBMITTED ON OCTOBER 24, 2025, UNDER THE MANUFACTURING REPORT NUMBER 3003442380-2025-05988. DUE TO AN ERROR, THE PR (B)(4) WAS SUBMITTED WITH THE MFR NUMBER INCORRECTLY. THIS CURRENT MDR IS BEING SUBMITTED TO CORRECT THE PREVIOUS REPORT. SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2025-05988. SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2025-05989. SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2025-05990. SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2025-05991. SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2025-05992. SUPPLEMENTAL REPORT 02 - (B)(4) - MDR 3003442380-2025-05993. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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: COMPLAINT INVESTIGATION RESULTS: AS A RESULT OF THE POST MARKET ACTIVITIES, THIS COMPLAINT HAS BEEN EVALUATED AS A TYPE 4 (TREND IDENTIFIED): THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE. CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION RESULTS: THIS COMPLAINT FALLS UNDER THE SCOPE OF THE CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES" AND WILL COVER INSET I (AUTOSOFT XC DHF-13.8 & 13.13) AND INSET II (AUTOSOFT 90 DHF-14 AND 14.3) PRODUCTS. ROOT CAUSE OF PROBLEM: THE ROOT CAUSE HAS BEEN IDENTIFIED AS: METHOD, MANPOWER, MEASUREMENT, MACHINE: CORRECTIVE ACTION AS A RESULT OF THE INVESTIGATION: THE ACTION PLAN AND DEADLINES IS AS FOLLOWED: THE FOLLOWING ACTIONS WERE ALREADY IMPLEMENTED IN THE NON-CONFORMANCE (NC) 1. INCLUDE THE DEFECT IN DOCUMENT 4805074 (WORK INSTRUCTION INSET LINE). 2. IMPROVE GUARDS OF THE CONVEYORS. 3. UPDATE TRAYS FOR THE STOCK OF CANNULAS. 4. UPDATE DOCUMENT 3A02003 (QUALITY SPECIFICATION FOR CATHETER FIXTURE FOR SKEWED CATHETERS) FOR INCLUDE THE HANDLING OF THE CATHETER DURING THE PROCESS. 5. UPDATE THE DOCUMENT 4805074 (WORK INSTRUCTION INSET LINE) TO INCLUDE THE PREVENTIVE ACTIONS IMPLEMENTED IN THE PROCESS (TRAYS). A REMAINING ACTION (TO ADDRESS DESIGN ROOT CAUSE) AND DEADLINES IS AS FOLLOWED: ADD CYLINDERS TO THE LID TO MAINTAIN IN POSITION THE NEEDLE AND CANNULA DURING TRANSPORTATION AND PRIOR USE (DATABASE 1771074- 30/SEP/2025).
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SIX EVENTS OF KINKED CANNULA ON (B)(6) 2025 . THE INFUSION SET WAS IN USE FOR 24 HOURS. PATIENT NOTICED SYMTPOMS WITHIN THREE HOURS OF INSERTION. THE SITE OF LOCATION WAS ABDOMEN. HIGH BLOOD GLUCOSE (600 MG/DL) WAS ADDRESSED USING INTRAVENOUS FLUIDS OF SALINE AND INSULIN. PATIENT WAS RELEASED ON (B)(6) 2025 . COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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 |
|---|---|---|---|---|---|---|---|
| 383510 | AUTOSOFT XC | UNO INSET I 12/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL UM-D | 1006922 | 6008240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |