MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-04 for MALLINCKRODT 109-70 manufactured by Mallinckrodt Medical.
[129454480]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[129454481]
According to the reporter, the tube disconnected from the patient due to separation of the tube connector from the actual tube in the patient's throat. The customer reported that patient required reconnection 7 times pushing the connector back into the tube portion of the tube. Finally, the respiratory therapist had to cut the tube and have been the supervisor with more strength to push the connector into the tube portion so it would hold. The patient was extubated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020889-2018-00133 |
| MDR Report Key | 8128487 |
| Date Received | 2018-12-04 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-11-07 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2018-12-04 |
| 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 03810 |
| Manufacturer Postal Code | 03810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MALLINCKRODT |
| Product Code | BSK |
| Date Received | 2018-12-04 |
| Returned To Mfg | 2018-12-03 |
| Model Number | 109-70 |
| Catalog Number | 109-70 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MALLINCKRODT MEDICAL |
| Manufacturer Address | CORNAMADDY ATHLONE 03810 03810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-12-04 |