MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for SILKO REBREATHING BAG 2.3 150700-000023 manufactured by Teleflex Medical.
[122171490]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122171491]
It was reported that the balloon leaked due to a hole near the seal of the straining clamp. Thus, the anesthesia ventilator failed its tests. As a result there was a report of a delay; however, there was no report of patient injury or complication due to the delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610520-2018-00012 |
| MDR Report Key | 7915066 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2018-09-27 |
| 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 | WILLY-RUSCH-STR. 4 - 10 |
| Manufacturer City | 71394 KERNEN 71394 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 71394 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SILKO REBREATHING BAG 2.3 |
| Generic Name | DEVICE, REBREATHING |
| Product Code | BYW |
| Date Received | 2018-09-27 |
| Returned To Mfg | 2018-12-12 |
| Catalog Number | 150700-000023 |
| Lot Number | P1442942 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 71394 KERNEN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |