MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-15 for POLYETHYLENE EVA DISPOSABLE SMOOTH TUBING 243301 manufactured by Tri-anim Health Services, Inc..
[117160416]
Our respiratory therapists reported that they have had several occurrences of the 10 mm disposable smooth interior tubing "unraveling. " the thin membrane holding the coils together breaks easily with little flexion applied to the circuit, far less than would be under normal use conditions. Manufacturer response for ventilator tubing, (per site reporter). The device is manufactured by (b)(4), distributed by (b)(4) and repackaged by (b)(4). The lot numbers on the repackaged tubes we have are 579100 and 578973. After making a-m systems aware of the problems, (b)(4) contacted (b)(4) and has begun the recall process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7784207 |
| MDR Report Key | 7784207 |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-28 |
| Report Date | 2018-08-08 |
| Date Reported to FDA | 2018-08-08 |
| Date Reported to Mfgr | 2018-08-15 |
| Date Added to Maude | 2018-08-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYETHYLENE EVA DISPOSABLE SMOOTH TUBING |
| Generic Name | TUBING, PRESSURE AND ACCESSORIES |
| Product Code | BYX |
| Date Received | 2018-08-15 |
| Model Number | 243301 |
| Catalog Number | 243301 |
| Lot Number | 579100/578973 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRI-ANIM HEALTH SERVICES, INC. |
| Manufacturer Address | 5000 TUTTLE CROSSING BLVD. DUBLIN OH 43016 US 43016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-15 |