INTERMITTENT
Report
- Report Number
- 3005778470-2020-00176
- Event Type
- Injury
- Date Received
- September 21, 2020
- Report Date
- August 27, 2020
- Manufacturer
- UNOMEDICAL S.R.O.
- Product Code
- KOD
- PMA / PMN Number
- K896729
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(4). A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: URINARY CATHETER IN QUESTION WAS MANUFACTURED UNDER SAP MATERIAL ID 1266041 AND MANUFACTURING LOT #9B00044 IN C2 IN FEBRUARY 2019 IN AMOUNT (B)(6) PCS ON PACKAGING MACHINE P010. LOT 9B00044 WAS STERILIZED UNDER STERILIZATION LOT # 26A190415. THE CATHETERS WERE ASSEMBLED UNDER SUBASSEMBLY LOT #9B00045 ON MACHINE A095. ACCORDING TO G905500 VER 32 SECTION 5.11. SUBSECTION 3 AND 4 . USED DURING PRODUCTION OF THE LOT THE VISUAL INSPECTION ACCORDING TO TM-443, TESTS ACCORDING TO TW-428 TEST METHOD FOR VISUAL AND TACTILE INSPECTION OF ASSEMBLED CATHETER TUBING FOR IRREGULARITIES WERE CARRIED DURING IN-PROCESS CONTROL. EACH CATHETERS WAS INSPECTED. RESULTS OF INSPECTION ARE RECORDED IN RELEVANT FORMS G905500. 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. THE CORRECT RAW MATERIAL WAS USED DURING LOT PRODUCTION. NO NONCONFORMITY HAD BEEN REGISTERED DURING THE PRODUCTION PROCESS OF THE MENTIONED LOT. A QUERY WAS RUN AGAINST ERP NUMBER 1266041 ON (B)(6) 2020 WHICH YIELDED IN TWO OCCURRENCE FROM (B)(6)2016 ¿ TW1398293 AND TW1399159 . BOTH COMPLAINTS WERE FROM THE SAME CUSTOMER. ONE COMPLAINT WAS RECEIVED FROM THE CUSTOMER BUT TWO COMPLAINTS WERE CREATED IN TW BECAUSE THE CUSTOMER MADE THE COMPLAINT TO TWO LOTS. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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.
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
MDR: 3005778470-2020-00176 / DEVICE 13 OF 25. (B)(6). MEDICAL DEVICE LIAISON. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).
IT WAS REPORTED THAT A ¿PATIENT PURCHASED THE FEMALE CATHETER FROM THE PHARMACY AND WHILE SHE WAS USING THE CATHETER SHE FACED DIFFICULTIES WHILE REMOVING IT. SHE INFORMED THE PHARMACY THAT SHE WAS FEELING UNCOMFORTABLE FROM THE LATERAL PORES WHEN SHE WAS REMOVING THE CATHETER AND THAT SHE WAS INJURED AND WAS HOSPITALIZED ONE WEEK BECAUSE OF INFECTION.¿ THE END USER HAD TO TAKE ANTIBACTERIAL DRUGS (BRAND UNKNOWN). THE END USER ALSO MENTIONS "SHE USED SEVERAL BRANDS OF CATHETERS (BRANDS INFORMATION WAS NOT PROVIDED) AND SHE INFORMED US THAT SHE IS FACING THE SAME INFECTIONS WITH ALL THE BRANDS THAT SHE HAS USED SINCE (B)(6) 2019". IT WAS FURTHER REPORTED THERE WAS TRACE BLEEDING AND ¿THAT SHE FELT THE PORES WERE STIFF.¿ THE END USER WENT ON TO INFORM THAT SHE DOESN'T KNOW THE EXACT NUMBER OF CATHETERS THAT WERE USED FROM THE PRODUCT LOT AND THE PRODUCT WAS SUFFICIENTLY LUBRICATED PRIOR TO INSERTION. IT WAS NOTED THAT THE DATE OF EVENT OCCURRED (B)(6) 2020. ADDITIONAL INFORMATION ATTEMPTS WERE MADE WITH NO NEW INFORMATION RECEIVED. NO PHOTOGRAPHS DEPICTING THE REPORTED COMPLAINT ISSUE WERE SUBMITTED BY THE COMPLAINANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1024077 | INTERMITTENT | CATHETER, UROLOGICAL | KOD | UNOMEDICAL S.R.O. | V417373 | 9B00044 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |