MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2017-04-13 for 2K8032 manufactured by Carefusion/bd.
[72752303]
Customer advocacy has reached out to customer to provide sample for the investigation. (b)(6) label was provided to the customer. At this time we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[72752304]
The customer reported that "during resuscitation and post intubation mask does not come off bag elbow during and after use". Customer reported no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[113290404]
Unfortunately the device sample was not available for further investigation. At this time the unable to disconnect failure mode cannot be confirmed. However based on similar complaints as a probable root cause it is considered that the current mirror finish surface on the elbow makes the mask very difficult to remove. The new textured surface finish on the elbow allows the mask to be easily removed as indented. A corrective and preventative action has also been opened to further investigate into this known failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00320 |
| MDR Report Key | 6490835 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2017-04-13 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-03-12 |
| Date Mfgr Received | 2017-05-23 |
| Date Added to Maude | 2017-04-13 |
| 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 | MINDY FABER |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION/BD |
| Manufacturer Street | CERRADA V NO.85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 8030673-4/27/17-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2K8032 |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-04-13 |
| Catalog Number | 2K8032 |
| Lot Number | 0001015634 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION/BD |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO.85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-13 |