QUICK SET
Report
- Report Number
- 3003442380-2025-14981
- Event Type
- Malfunction
- Date Received
- October 10, 2025
- Date of Event
- September 15, 2025
- Report Date
- October 2, 2025
- Manufacturer
- UNOMEDICAL DEVICES S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- K160648
- Adverse Event
- Yes
- 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: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011624, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 30-SEP-2025 AGAINST "FINAL REPORTING DECISION" EQUAL "SERIOUS INJURY AND DEATH", "LOT NUMBER" CRITERIA EQUAL LOT NUMBER "6011624". (B)(4). NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011624 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGED IN THE MULTIVAC 12 ON 12-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT IN FINAL OUTGOING INSPECTION A SAMPLE WAS FOUND WITH A TWISTED NEEDLE. DUE TO THE ORDER QUANTITY, A SAMPLING PLAN WAS NOT NECESSARY, THE BATCH WAS RELEASED. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. THE SUB-ASSEMBLY, ASSEMBLY LOT 5B00455 WAS MANUFACTURED ACCORDING TO THE (B)(4) VERSION 27, ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT 5B00456 WAS MANUFACTURED ACCORDING TO THE (B)(4) VERSION 27, ON 12-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT 5B01777 WAS MANUFACTURED ACCORDING TO THE (B)(4) VERSION 27, ON 09-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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. GLUING OF TUBING: THE LOT 5B00438 WAS GLUED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04 AND 08, ON 08-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B01648 WAS GLUED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04, ON 08-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B00439 WAS MANUFACTURED ACCORDING TO THE WI VERSION 42 AND MANUFACTURED IN THE MACHINE 04 AND 08, ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WI GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES PASSED OUT 10 SAMPLES PASSED THE TEST FOR THE CODE. NO MALFUNCTION BASED ON COMPLAINT INFORMATION. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES. NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, NO FURTHER ACTIONS ARE REQUIRED, 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.
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: UNITED STATES. 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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011624, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THRESHOLD ANALYSIS: A QUERY WAS RUN ON 30-SEP-2025 AGAINST "FINAL REPORTING DECISION" EQUAL "SERIOUS INJURY AND DEATH", "LOT NUMBER" CRITERIA EQUAL LOT NUMBER "6011624". THE COUNT OF COMPLAINT IS 1 WHICH IS BELOW 3. NO FURTHER STATISTICAL TRENDING ANALYSIS IS REQUIRED. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011624 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 82 AND PACKAGED IN THE MULTIVAC 12 ON 12-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT IN FINAL OUTGOING INSPECTION A SAMPLE WAS FOUND WITH A TWISTED NEEDLE. DUE TO THE ORDER QUANTITY, A SAMPLING PLAN WAS NOT NECESSARY, THE BATCH WAS RELEASED. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. THE SUB-ASSEMBLY, ASSEMBLY LOT 5B00455 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 27, ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT 5B00456 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 27, ON 12-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY LOT 5B01777 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 27, ON 09-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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. GLUING OF TUBING: THE LOT 5B00438 WAS GLUED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE 04 AND 08, ON 08-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B01648 WAS GLUED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE 04, ON 08-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5B00439 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 42 AND MANUFACTURED IN THE MACHINE 04 AND 08, ON 11-FEB-2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE 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. TEST RESULTS: IN ORDER TO TEST THE PRODUCT, NO PHOTO OR PHYSICAL SAMPLE WAS PROVIDED, THEREFORE, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH: WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3: 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST AND WORK INSTRUCTION (WI) GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2: 10 SAMPLES PASSED OUT 10 SAMPLES PASSED THE TEST FOR THE CODE IDD-PMC11.03 NO MALFUNCTION BASED ON COMPLAINT INFORMATION. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO PHYSICAL SAMPLES WERE RETURNED, NO DEFECT ON TEST OF REFERENCE SAMPLES. NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO THRESHOLDS IDENTIFIED FOR THE LOT IN QUESTION AND SERIOUS INJURY/DEATH, NO FURTHER ACTIONS ARE REQUIRED, 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.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED DUE TO HYPOGLYCEMIA EVENT ON (B)(6) 2025. BLOOD GLUCOSE LEVEL WAS 20 MG/DL AT THE TIME OF THE EVENT AND GOT TREATED WITH INTRAVENOUS (IV) DEXTROSE. THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 315455 | QUICK SET | UNO QUICK-SET 60/9 SC1 MECA | FPA | UNOMEDICAL DEVICES S.A. DE C.V. | MMT-397A | 6011624 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| H |