MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-12 for PAEDIATRIC PARALLEL CIRCUIT 96" Y-PIECE LUER ELBOW 2 X B/VIRAL FILTERS 1L R BAG 038-02-713U manufactured by Flexicare Medical Dongguan Ltd..
[138546521]
Root cause: brittleness of tubing material corrective actions: increase level of plasticiser (eva), modification to mold tool to remove any sharp edges, increased qa/operator inspection.
Patient Sequence No: 1, Text Type: N, H10
[138546522]
The seam on the side of the tubing failed and cause of failure to be able to ventilate ab anesthetized patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006061749-2019-00006 |
| MDR Report Key | 8412557 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-12 |
| Date of Report | 2019-03-12 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2019-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR RICHARD DOWNS |
| Manufacturer Street | CYNON VALLEY BUSINESS PARK |
| Manufacturer City | MOUNTAIN ASH, RCT CF454ER |
| Manufacturer Country | UK |
| Manufacturer Postal | CF45 4ER |
| Manufacturer G1 | FLEXICARE MEDICAL DONGGUAN LTD. |
| Manufacturer Street | NO. B-15 XICHENG IND ZONE 1 HENGLI TOWN |
| Manufacturer City | DONGGUAN CITY, GUANGDONG 523460 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 523460 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAEDIATRIC PARALLEL CIRCUIT 96" Y-PIECE LUER ELBOW 2 X B/VIRAL FILTERS 1L R BAG |
| Generic Name | PAEDIATRIC ANAESTHESIA CIRCUIT |
| Product Code | OFP |
| Date Received | 2019-03-12 |
| Model Number | 038-02-713U |
| Catalog Number | 038-02-713U |
| Lot Number | 180701295 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FLEXICARE MEDICAL DONGGUAN LTD. |
| Manufacturer Address | NO. B-15 XICHENG IND ZONE 1 HENGLI TOWN DONGGUAN CITY, GUANGDONG 523460 CH 523460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-12 |