GENTLECATH GLIDE
Report
- Report Number
- 3005778470-2024-00274
- Event Type
- Malfunction
- Date Received
- January 23, 2024
- Report Date
- January 12, 2024
- Manufacturer
- UNOMEDICAL S.R.O.
- Product Code
- GBM
- PMA / PMN Number
- K181206
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A2: SEX: MALE BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 , MANUFACTURING SITE: 3005778470.
A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED ON PACKAGING MACHINE P009 IN AMOUNT (B)(4). ACCORDING TO G905704 VER 24.0 WITHIN IN-PROCESS THE PEELTEST IS CARRIED OUT. POINT 5.11.3 PEELPACK MUST NOT BE SEALED SO STRONG THAT PAPER RESIDUES REMAINED ON THE FOIL OR PAPER TEARS. SEAL SHOULD BE ENOUGH STRONG TO KEEP PAPER AND FOIL TOGETHER WITHOUT ANY IRREGULARITIES. REVIEW OF TEST RESULTS WAS CARRIED OUT AND ALL SAMPLES PASSED PEELTEST REQUIREMENTS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING AND PACKAGING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION AND STERILIZATION PROCESS OF THE MENTIONED LOT. DURING PACKAGING PROCESS WAS USED PAPER UNDER LOT 0F/31358. SIMILAR COMPLAINTS RECEIVED ON THE LOT IN QUESTION WERE RECEIVED. PERCENTAGE AFFECTED PIECES AGAINST THE LOT EQUALS (B)(4). THE DEFECT REPORTED IS BELOW THE AQL 0,4. BASED ON INCREASED TREND OF RECEIVED COMPLAINTS WAS OPENED NEW CAPA#1832524 - INCREASED COMPLAINT TREND RELATED TO THE ISSUE PEELPACK PAPER TEARING UNEVENLY WHEN OPENING GENTLECATH GLIDE. CAPA OPENED 20/FEB/2024 AND IT IS IN INVESTIGATION STATE. WITHIN PRELIMINARY INVESTIGATION WAS TAKEN IN CONSIDERATION SEVERAL CAUSES WHICH CAN HAVE AN IMPACT ON QUALITY OF POUCH SEAL. THE FOLLOWING CAUSES HAVE BEEN ASSESSED AS MOST SIGNIFICANT IMPACTORS: IN SEPTEMBER 2022 FOR US PORTFOLIO AND NOVEMBER 2022 FOR EUR PORTFOLIO CHANGE OF STERILIZATION PROCESS HAS BEEN CHANGED FROM ETO TO XRAY, WHICH MAY HAVE IMPACT ON INCREASED WELD STRENGTH AND/OR CAUSE DEGRADATION OF PRIMARY PACK PAPER TO BE MORE FRAGILE, BUT IT IS NOT DIRECTLY LINKED TO INCREASED COMPLAINTS, AS MOST OF AFFECTED BATCHES WERE PRODUCED IN FEBRUARY TO APRIL 2023. WELD STRENGTH BETWEEN PRIMARY PACK PAPER AND FILM IS TESTED IN PRODUCTION BY BURST TEST (WITH DEFINED REQUIRED MINIMUM 50 CM H2O). COMPARISON OF BURST TEST RESULTS FROM BATCHES PRODUCED BETWEEN SEPTEMBER 2022 AND MAY 2023 SHOWS, THAT THERE IS STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN PAPER BATCH OF/31358 AND OTHER PAPER BATCHES. BASED ON THIS, IT WAS DETERMINED THAT PAPER BATCH IS MOST SIGNIFICANT IMPACTOR. AS IMMEDIATE ACTIONS STOP SHIP AND HHE HAVE BEEN INITIATED - REFER TO CORRECTIONS TW (B)(4). AWARENESS OF OPERATORS ON PACKAGING LINE TO STOP PRODUCTION AND ESCALATE IF HIGHER BURST TEST RESULTS WILL BE OBSERVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 3005778470.
END USER REPORTS "PACKAGING HARDER TO OPEN AND BREAKS APART". THERE WAS NO HARM REPORTED.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1854369 | GENTLECATH GLIDE | CATHETER, URETHRAL | GBM | UNOMEDICAL S.R.O. | 421910 | 3C01306 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |