PORTEX
Report
- Report Number
- 3012307300-2021-00620
- Event Type
- Malfunction
- Date Received
- January 21, 2021
- Report Date
- January 21, 2021
- Manufacturer
- ST PAUL
- Product Code
- JOH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
FOLLOWING DHRS WERE REVIEWED: UNIPERC FINISH GOOD WORK ORDER 100/897/080CZ LOT 3986061, MANUFACTURING DATE 2020-06-04, QUANTITY 245PCS; TRACHEOSTOMY TUBE ASSEMBLY WORK ORDER 007/842/080CZ LOT 3852764 (1PCS USED IN FINISH GOOD WORK ORDER), MANUFACTURING DATE 2019-07-15, QUANTITY 243PCS. TRACHEOSTOMY TUBE ASSEMBLY WORK ORDER 007/842/080CZ LOT 3977654 (11PCS USED IN FINISH GOOD WORK ORDER), MANUFACTURING DATE 2020-04-08, QUANTITY 234PCS. TRACHEOSTOMY TUBE ASSEMBLY WORK ORDER 007/842/080CZ LOT 3996131 (170PCS USED IN FINISH GOOD WORK ORDER), MANUFACTURING DATE 2020-05-11, QUANTITY 170PCS. TRACHEOSTOMY TUBE ASSEMBLY WORK ORDER 007/842/080CZ LOT 4007021 (63PCS USED IN FINISH GOOD WORK ORDER), MANUFACTURING DATE 2020-06-01, QUANTITY 222PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3830796 (11PCS USED IN 3852764), MANUFACTURING DATE 2019-05-24, QUANTITY 250PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3843031 (95PCS USED IN 3852764), MANUFACTURING DATE 2019-06-26, QUANTITY 250PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3843032 (135PCS USED IN 3852764), MANUFACTURING DATE 2019-06-27, QUANTITY 250PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3852766 (2PCS USED IN 3852764), MANUFACTURING DATE 2019-07-10, QUANTITY 250PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3977651 (217 PCS USED IN 3977654, 27PCS USED IN 4007021), MANUFACTURING DATE 2020-04-08, QUANTITY 250PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3965856 (17 PCS USED IN 3977654), MANUFACTURING DATE 2020-03-17, QUANTITY 250PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3992743 (170 PCS USED IN 3996131, 31PCS USED IN 4007021), MANUFACTURING DATE 2020-04-30, QUANTITY 221PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3998331 (99 PCS USED IN 4007021), MANUFACTURING DATE 2020-05-18, QUANTITY 100PCS. FLANGE ASSEMBLY WORK ORDER 007/850/280 LOT 3998330 (65 PCS USED IN 4007021), MANUFACTURING DATE 2020-05-18, QUANTITY 250PCS. MOLDED FLANGE RAW MATERIAL 007/850/080 LOT 18512 (250PCS USED IN 3830796, 247PCS USED IN 3843031, 250PCS USED IN 3843030, 250PCS USED IN 3852766), 5372PCS RECEIVED BETWEEN MAY AND SEPTEMBER 2019. MOLDED FLANGE RAW MATERIAL 007/850/080 LOT 18116 (3PCS USED IN 3830796, 247PCS USED IN 3843031), 2380PCS RECEIVED IN JUNE 2018. MOLDED FLANGE RAW MATERIAL 007/850/080 LOT 19322 (250PCS USED IN 3977651, 250PCS USED IN 3965856, 40PCS USED IN 3992743), 3122PCS RECEIVED BETWEEN FEBRUARY AND MARCH 2020, THIS BATCH WAS REJECTED DURING INCOMING INSPECTION AND THEN 100% REINSPECTED PRIOR USE, REASON FOR REJECTION WAS NOT IN RELATION WITH THIS CUSTOMER COMPLAINT. MOLDED FLANGE RAW MATERIAL 007/850/080 LOT 19507 (181PCS USED IN 3992743), 616PCS RECEIVED IN APRIL 2020, THIS BATCH WAS REJECTED DURING INCOMING INSPECTION AND THEN 100% REINSPECTED PRIOR USE, REASON FOR REJECTION WAS NOT IN RELATION WITH THIS CUSTOMER COMPLAINT. MOLDED FLANGE RAW MATERIAL 007/850/080 LOT 20080 (100PCS USED IN 3998331, 250PCS USED IN 3998330), 3808PCS RECEIVED BETWEEN MAY AND JULY 2020. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT.
INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC CLIP DID NOT COME OVER AND CLICK INTO PLACE AND HAD TO BE TAKEN OUT AND A NEW ONE INSERTED WHICH FASTENED. NO PATIENT ADVERSE EVENTS REPORTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102774 | PORTEX | TRACHEOSTOMY | JOH | ST PAUL | 8.0MM | 3986061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |