MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-28 for SHILEY 126037 manufactured by Mallinckrodt Medical.
[188146227]
Evaluation summary: one sample returned for evaluation and the reported event was not confirmed. The returned unit was inflated without any issue. A leak test under water was done and no leakage was detected. The returned unit remained inflated for a four hour period and no leakage was detected. The bronchial and tracheal lumens were blocked off independently and air passed through each side. No leakage was detected. The most probable root cause is an inflation device remained in the inflation device allowing air to escape. Information has been added to the database and trends will continue to be monitored. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188146228]
According to the reporter, prior to use, the device's airbag had leakage. It was replaced with another tube, and it was normal. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020889-2019-00166 |
| MDR Report Key | 9390166 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-28 |
| Date of Report | 2019-11-28 |
| Date Mfgr Received | 2019-11-26 |
| Device Manufacturer Date | 2018-05-09 |
| Date Added to Maude | 2019-11-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MALLINCKRODT MEDICAL |
| Manufacturer Street | CORNAMADDY |
| Manufacturer City | ATHLONE 3810 |
| Manufacturer Postal Code | 3810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILEY |
| Generic Name | TUBE, BRONCHIAL (W/WO CONNECTOR) |
| Product Code | BTS |
| Date Received | 2019-11-28 |
| Model Number | 126037 |
| Catalog Number | 126037 |
| Lot Number | 201804310X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT MEDICAL |
| Manufacturer Address | CORNAMADDY ATHLONE 3810 3810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-28 |