MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG 001203-A manufactured by Carefusion, Inc.
[53782451]
(b)(4). The customer reported that the physical sample is unavailable for return and the lot number is unknown. A photograph of the reported issue was provided by the customer. If any additional information becomes available a supplemental submission will be filed.
Patient Sequence No: 1, Text Type: N, H10
[53782452]
The customer reported, "the disc on the inside of the mask came off and was inhaled by the patient. The patient was able to cough the disc up. The patient coughed it up several days after discharge. There was no harm to the patient".
Patient Sequence No: 1, Text Type: D, B5
[61253135]
Unfortunately the device used during this reported incident was disposed of by the end-user, and no representative sample was available for further investigation. Without a sample for investigation the reported failure mode could not be confirmed. Carefusion/bd could not review the device history record for the reported device, the lot number was not available. Two years of compliant trends were evaluated and no trend was detected. At this time carefusion/bd is unable to determine a root cause for the failure reported. No corrective actions will be implemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2016-00220 |
| MDR Report Key | 5923137 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-08-12 |
| Date Mfgr Received | 2016-11-08 |
| Date Added to Maude | 2016-09-01 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | CERRADA V NO. 85., PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG |
| Generic Name | MASK, OXYGEN, NON-REBREATHING |
| Product Code | KGB |
| Date Received | 2016-09-01 |
| Catalog Number | 001203-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-09-01 |