MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-02-25 for PAEDIATRIC FLEXI-LOCK PARALLEL CIRCUIT 96" WITH Y-PIECE LUER ELBOW MINI FILTER 038-02-612U manufactured by Flexicare Medical Dongguan Ltd..
[141221311]
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
[141221312]
Anesthesia provider performed leak-test on a paediatric flexi-lock parallel circuit 96" with y-piece luer elbow mini bv filter 1l res bag prior to induction of anesthesia on a pediatric patient. When the anesthesia provider attempted to ventilate the patient, a leak in the circuit was apparent. The patient was then ventilated with an ambu-bag and the circuit was changed. Upon inspection of the original circuit, a crack in the tubing was found.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006061749-2019-00002 |
| MDR Report Key | 8365625 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-01-16 |
| Device Manufacturer Date | 2018-06-30 |
| Date Added to Maude | 2019-02-25 |
| 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 FLEXI-LOCK PARALLEL CIRCUIT 96" WITH Y-PIECE LUER ELBOW MINI FILTER |
| Generic Name | ANESTHESIA BREATHING CIRCUIT - EXPANDABLE |
| Product Code | OFP |
| Date Received | 2019-02-25 |
| Model Number | 038-02-612U |
| Catalog Number | 038-02-612U |
| Lot Number | 180601433 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-02-25 |