TECA® DISP DMN NEEDLE ELECTRODE, 1"(25MM)X0.36MM
Report
- Report Number
- 3005581270-2024-00007
- Event Type
- Malfunction
- Date Received
- October 30, 2024
- Date of Event
- October 1, 2024
- Report Date
- April 14, 2025
- Manufacturer
- NATUS MANUFACTURING LIMITED
- Product Code
- IKT
- PMA / PMN Number
- K973442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4) ADDED EXPIRATION DATE TO SECTION D4 ADDED MANUFACTURER DATE TO SECTION H4. PER (B)(4) REV 13 RISK ANALYSIS SPREADSHEET FOR MONOPOLAR TP NEEDLE ELECTRODES HAZARD 6.6 - NEEDLES ARE THIN / FLEXIBLE MAY BREAK. EFFECTS (HARM) - WORST CASE - CANNULA END BREAKS OFF INSIDE PATIENT AND HAS TO BE SURGICALLY REMOVED. RESIDUAL RISK - MODERATE. RELATED TO CAPA005709 WHICH NOTES THE FOLLOWING: INITIAL SCREENING OF COMPLAINT DETERMINED THAT THE RECEIVED COMPLAINT IS RELATED TO A LOT NUMBER MANUFACTURED WITH THE RECENTLY INTRODUCED BLUE COATING (PRJ#000663). ROOT CAUSE ANALYSIS: TRIALS COMPLETED AT THE COATING SUPPLIER SUPPORTS THE ROOT CAUSE INVESTIGATION, WHERE TIP DAMAGE IS EVIDENT POST JIGGING OF THE NEEDLES FROM THE DISTAL END. IMPACT OF DAMAGED NEEDLE TIPS WILL RESULT IN NEEDLES NOT BEING SHARP AND DIFFICULT TO INSERT, THUS LEADING TO POTENTIAL BENDING AND DEFLECTING OF THE NEEDLES DURING INITIAL INSERTION. THE ROOT CAUSE HAS BEEN IDENTIFIED AND ONLY MONOPOLAR TP NEEDLES ARE AFFECTED AND NO OTHER NEEDLE TYPES. CORRECTIVE AND PREVENTIVE ACTION PLAN: 1. NEW VISION SYSTEM AT NATUS, IQ AND TMV AT 80X. CREATE NEW VAS. UPDATE PROCESS VALIDATION PROCEDURE TO ADD GUIDANCE FOR ASSESSMENT OF INSPECTION MAGNIFICATION LEVEL. 2. ISSUE (B)(4) TO THE (COATING SUPPLIER) TO INCLUDE THE FOLLOWING ACTIONS: NEW JIG FIXTURE SYSTEM. UPDATE WIS, AND IQ. VISUAL AIDS. QUALIFY VISUAL INSPECTION AT 80X. CREATE PQ PROTOCOL. ALL FUTURE NEEDLE TIP INSPECTIONS FOR TP NEEDLES ARE CARRIED OUT AND VALIDATED AT 80X. 3. ISSUE (B)(4) TO THE (NEEDLE BLANK SUPPLIER) TO INCLUDE THE FOLLOWING ACTIONS: UPDATE DRAWINGS TO INCLUDE RAD DIMENSIONS AND TOLERANCE FOR STRAIGHTNESS. INCORPORATE ADDITIONAL IN-PROCESS VISUAL INSPECTION FOR NEEDLE TIP DAMAGE. UPDATE PACKAGING CONFIGURATION TO REDUCE RISK OF DAMAGE IN TRANSIT. REVIEW AND APPROVALS OF ACTIONS FOR CAPA005709 ARE CURRENLY ONGOING.
FOLLOW UP REPORT 002 REF NATUS COMPLAINT#: (B)(4). DEVICE HISTORY RECORD REVIEW: PART: 902-DMF25-TP, LOT: U2402B09 WAS BUILT ON WORK ORDER: (B)(4) FOR PQ201 PROCESS QUALIFICATION PROTOCOL FOR MONOPOLAR TP NEEDLE COATING DESIGN CHANGE. THE DHR SHOWS A TOTAL OF 608 NEEDLES WERE SCRAPPED OF (B)(4) NEEDLES PRODUCED. THE SCRAP PARTS WERE ACROSS 6 STEPS OF THE WORK ORDER. 6.3% FAILURE OVERALL. THE OVERALL FAILURE OF STEP 50 (KOMAX 2 CRIMP AND VISION INSPECTION) AND STEP 60 ( INSPECTION PTFE FEEL TEST) WAS ABOVE THE 1%. ON BOTH OCCASIONS AN ENGINEER WAS CALLED AND ASSESSED THE ISSUES. ENGINEER INSTRUCTED TO CONTINUE PRODUCTION. PRODUCT EXAMINATION: THE FAILED PRODUCT WAS NOT RETURNED. INVESTIGATION SUMMARY: THE CUSTOMER DID NOT RETURN THE BROKEN NEEDLE. THE CUSTOMER RETURNED REMAINING UNUSED BOXES OF LOT#: U2402B09. THE DEFECT WAS NOT PRESENT ON THE RETURNED PRODUCT. THE DHR REVIEW DID NOT SHOW ANY ANOMALIES FOR THE COMPLAINT INCLUDING A REVIEW OF ALL APPLICABLE MEASUREMENTS. FAILURE CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED. IMPACT TO OTHER PRODUCT(S). A SERIES OF COMPLAINTS WERE RECEIVED FOR ALL BLUE COATED MONOPOLAR NEEDLES. CAPA: 005709 WAS RAISED TO INVESTIGATE THE ISSUE. DETAILS OF CAPA: 005709 WERE DOCUMENTED IN FOLLOW UP 001. EFFECTIVITY CHECK IS DUE: 05/30/2025.
INITIAL REPORT REF NATUS COMPLAINT # (B)(4). THE CUSTOMER IS REQUESTED TO RETURN THE NEEDLES FOR EVALUATION. FURTHER INVESTIGATION TO BE CARRIED OUT.
PART 902-DMF25-TP MONOPOLAR NEEDLE. THE ISSUE WAS WITH THE PHYSICIAN, NOT THE PATIENT. THE NEEDLE BROKE OFF DURING THE EMG STUDY AND THE PHYSICIAN GOT POKED IN HIS FINGER BY THE NEEDLE. NO INFECTION. NO FURTHER HOSPITALIZATION REQUIRED.
PART: 902-DMF25-TP MONOPOLAR NEEDLE. THE ISSUE WAS WITH THE PHYSICIAN, NOT THE PATIENT. THE NEEDLE BROKE OFF DURING THE EMG STUDY AND THE PHYSICIAN GOT POKED IN HIS FINGER BY THE NEEDLE. NO INFECTION. NO FURTHER HOSPITALIZATION REQUIRED.
PART 902-DMF25-TP MONOPOLAR NEEDLE. THE ISSUE WAS WITH THE PHYSICIAN, NOT THE PATIENT. THE NEEDLE BROKE OFF DURING THE EMG STUDY AND THE PHYSICIAN GOT POKED IN HIS FINGER BY THE NEEDLE. NO INFECTION. NO FURTHER HOSPITALIZATION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1964924 | TECA® DISP DMN NEEDLE ELECTRODE, 1"(25MM)X0.36MM | TECA® DISP DMN NEEDLE ELECTRODE, 1"(25MM)X0.36MM | IKT | NATUS MANUFACTURING LIMITED | 902-DMF25-TP | U2402B09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |