MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for RUSCH STRETCH NECK REBREATH BAG 153000020 manufactured by Teleflex Medical.
[90297999]
(b)(4). The device involved in this complaint has not been received by the manufacturer at the time of this report. The investigation into this complaint is still in progress.
Patient Sequence No: 1, Text Type: N, H10
[90298000]
Customer complaint alleges there is a leak where the bag "connects to the machine". Alleged defect reported as detected during use. There was no report of patient injury or consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2017-00216 |
| MDR Report Key | 6941243 |
| Date Received | 2017-10-11 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-09-21 |
| Date Mfgr Received | 2017-11-17 |
| Date Added to Maude | 2017-10-11 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RUSCH STRETCH NECK REBREATH BAG |
| Generic Name | BAG, RESERVOIR |
| Product Code | BTC |
| Date Received | 2017-10-11 |
| Catalog Number | 153000020 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-11 |