PORTEX SILICONISED PVC SOFT-SEAL CUFF ORAL/NASAL
Report
- Report Number
- 9617604-2024-00107
- Event Type
- Injury
- Date Received
- February 8, 2024
- Date of Event
- June 19, 2023
- Report Date
- August 23, 2024
- Manufacturer
- SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
- Product Code
- BTR
- PMA / PMN Number
- K790312
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- 003
Narratives
B1, B2, H1, H2 AND H6 IMPACT CODE HAS BEEN UPDATED.
NO PRODUCT OR PHOTOS WERE RETURNED THEREFORE NO DEVICE ANALYSIS COULD BE COMPLETED. A DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THERE WERE NO DISCREPANCIES OR NON-CONFORMANCES DURING THE MANUFACTURING OF THE REPORTED LOT NUMBER. IF THE PRODUCT IS RETURNED THE MANUFACTURER WILL RE-OPEN THE COMPLAINT FOR FURTHER DEVICE ANALYSIS.
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
GCM RECEIVED AN EMAIL VIA SERVICE CLOUD ON (B)(6) 2024 FROM (B)(6), PHARMAMED-(B)(6), REGARDING A TRACHEAL TUBE SILICONISED PVC SOFT-SEAL CUFF ORAL/NASAL6.0MM 10/BX WITH LN 3955938. IT WAS STATED THAT DURING THE OPERATIVE PROCEDURE, THERE WAS EXTERNAL COMPRESSION OF THE TUBE IN ENDOLARYNGEAL PATHOLOGY. THE EVENTS WERE DISPERSED, ONCE IN A PEDIATRIC INTENSIVE CARE UNIT WHERE THE TUBE WAS OBSTRUCTED BY AN UNEXPLAINED EXTERNAL PRESSURE, AND THEN TWICE IN ADULTS WITH LARYNGEAL TUMORS. IN ALL CASES, IT WAS AN ENDOLARYNGEAL PATHOLOGY AND DIFFICULT INTUBATION. THE MANAGEMENT AND ANESTHESIA MANAGEMENT, WHICH FORMED A GROUP, WERE INFORMED ABOUT THE SERIOUS COMPLICATION. A REQUEST HAS BEEN SENT TO THE MANUFACTURERS TO DELIVER ALL DOCUMENTATION ON THE TUBES. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. (B)(6) 2024 UPDATE: GCM RECEIVED AN EMAIL ON (B)(6) 2024 FROM (B)(6) INFORMING THAT FROM THE PREVIOUS DISTRIBUTOR THEY RECEIVED THE FOLLOWING INFORMATION: LOT 4109996 IS FOR 100/141/035 (SOLD ON (B)(6)2021- (B)(4) AND (B)(6) 2022- (B)(4)), LOT 3955938 IS FOR 100/166/060 (SOLD SEVERAL TIMES BETWEEN (B)(6) 2020- (B)(6) 2022). FOR 100/141/030 THEY DON¿T HAVE INFORMATION AS THE CUSTOMER DID NOT SPECIFY IT. (B)(6) (B)(6) 2024. UPDATE: IN CLARIFICATION TO ABOVE DOCUMENTATION, THE EVENT HAPPENED IN ADULT WITH LARYNGEAL TUMOR WHERE THE TUBE WAS OBSTRUCTED BY AN UNEXPLAINED EXTERNAL PRESSURE. (B)(6) 2024 UPDATE: IN CLARIFICATION TO ABOVE DOCUMENTATION, THERE WAS KNOWN PATIENT INVOLVEMENT INSTEAD OF NO PATIENT INVOLVEMENT. IT WAS ALSO DISCOVERED DURING THE OPERATION, SO PATIENTS WERE INVOLVED. (B)(6) 2024 UPDATE: ADDITIONAL INFORMATION WAS PROVIDED FROM (B)(4), THE SLOVENIAN COMPETENT AUTHORITY, (B)(6) 2024 INDICATING ONE OF THE PATIENT RELATED EVENTS ENDED WITH SEVERE BRAIN DAMAGE. THIS INFORMATION WAS PROVIDED TO (B)(4) BY THE DOCTOR INVOLVED IN THE EVENTS. THE REPORT OF BRAIN DAMAGE IS BEING DOCUMENTED IN THE THREE RELATED COMPLAINT RECORDS AS IT IS UNKNOWN AT THIS TIME WHICH CASE IS ASSOCIATED WITH THE BRAIN DAMAGE REPORT. THIS INFORMATION WAS ADDED VIA AN ATTACHMENT WHICH WAS UPLOADED TO THE COMPLAINT FILE ON (B)(6) 2024. (B)(6) 2024. UPDATE: ADDITIONAL INFORMATION RECEIVED (B)(6) 2024 DURING A CALL WITH (B)(6), ICU MEDICAL HEAD OF (B)(6), (B)(6) (PHARMAMED), (B)(6) -HEAD OF DEPARTMENT OF OTORHINOLARYNGOLOGY, UNIVERSITY MEDICAL CENTER (B)(6), QA PERSON, COLLECTING INCIDENTS, NEAR MISSES, ETC. AND (B)(6) - ENT, HEAD AND NECK SURGEON. MAIN ISSUE IDENTIFIED IS WITH THE DIFFICULT CASES WHERE ANATOMICAL DISTURBANCES SUCH AS OEDEMA, TUMOR, ETC. ARE PRESENT. THE DOCTOR TYPICALLY GETS 1 SHOT IN INTUBATION AS IT MIGHT START TO BLEED. THEY RETROSPECTIVELY CHECKED SITUATIONS AND IDENTIFIED: ¿ BEFORE COVID ¿ HOSPITAL USED REINFORCED SILICONIZED OR SILICON (WIRE ENFORCED) OR PCV TUBES. ¿ AFTER COVID - SILICONIZED TUBES. TYPICALLY, THE INTUBATION GOES SMOOTHLY, BUT DUE TO EXTERNAL COMPRESSION, NO VENTILATION IS POSSIBLE. TUBES ARE THERMOPLASTIC MATERIALS, BECOME SOFTER AT HIGHER TEMPERATURES AND THEREFORE BECOME SOFTER INSIDE THE PATIENT. OR THE DEVICE SOFTENS AS IT¿S BEING PASSED AROUND BETWEEN DOCTORS AND NURSES BEFORE BEING USED. LAST YEAR (B)(6) THEY IMPLEMENTED A PROCEDURE STATING THAT IN CASES WITH EXPECTED DIFFICULT PATHOLOGY, INTUBATION SHOULD BE DONE USING MORE RIGID TUBES, SUCH AS PVC TUBES. MOST PROBLEMS WERE OBSERVED IN SMALLER DIAMETER TUBES, SMALL COMPRESSION, HIGH RESISTANCE CHANGE. NUMEROUS (RESOLVED) EVENTS WERE REPORTED INTERNALLY ¿ NO MAJOR INCIDENTS. THESE WERE NOT REPORTED TO THE AUTHORITIES AND NOT INVESTIGATED. AS THEY WERE NOW ABLE TO LINK THE CASES TO SILICONIZED TUBING, THEY DECIDED TO REPORT TO (B)(4) AND OTHER HOSPITALS IN THE COUNTRY. THIS IS THE ADDITIONAL INFORMATION GAINED DURING THE CALL RELATIVE TO THE INCIDENT RECORDED IN THIS COMPLAINT FILE. ENDO LARYNGEAL TUMOR - CASE (B)(6) 2023. DURING INTUBATION THE INSTRUMENT PASSED, FIBER OPTICALLY, AND AFTER RETRACTION VENTILATION WAS NOT POSSIBLE. RESOLVED VIA NECK ACCESS. NOT IN THE BOX (ITEM ON SURGICAL TRAY) - ITEM 100/166/060 ¿ LOT 3955938. (B)(6) 2024 (B)(6).
IT WAS REPORTED THAT DURING THE OPERATIVE PROCEDURE, THERE WAS EXTERNAL COMPRESSION OF THE TUBE IN THE ENDOLARYNGEAL PATHOLOGY. PATIENT WAS AN "ADULT WITH LARYNGEAL TUMORS." EVENT WAS REPORTED AS A DIFFICULT INTUBATION. "THE MANAGEMENT AND ANESTHESIA MANAGEMENT, WHICH FORMED A GROUP, WERE INFORMED ABOUT THE SERIOUS COMPLICATION." NO PATIENT HARM/ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1791358 | PORTEX SILICONISED PVC SOFT-SEAL CUFF ORAL/NASAL | TUBE, TRACHEAL (W/WO CONNECTOR) | BTR | SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. | 3955938 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |