MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-29 for RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS 2K8032 manufactured by Carefusion/bd.
[74012200]
Customer advocacy has reached out to customer to provide sample for the investigation. Ups 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
[74012201]
The customer reported that the tubing detaches from the o2 inlet during bagging. Reported item was being used on patient. No patient harm or medical intervention required. The customer reported via email "that the patient did not have a low oxygen saturation, the device was replaced immediately upon noticing the issue and the procedure was completed with another device".
Patient Sequence No: 1, Text Type: D, B5
[110217120]
One opened sample was received for further evaluation. During the visual inspection it was observed that the tubing was disassembled from the resuscitator. Solvent remnant was observed between the pvc tubing and the treaded housing. It is considered that an insufficient amount of solvent between these components could provoke this type of disconnection. Therefore the reported failure mode has been confirmed. After a thorough investigation of the manufacturing procedure it is considered that the root cause of the disconnection reported is related to the assembly personnel not following procedure during solvent application. Personnel have been retrained on the solvent application procedure to prevent insufficient application in the future.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00330 |
| MDR Report Key | 6533005 |
| Date Received | 2017-04-29 |
| Date of Report | 2017-09-08 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-08-09 |
| Date Added to Maude | 2017-04-29 |
| 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 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2017-04-29 |
| Returned To Mfg | 2017-06-08 |
| Catalog Number | 2K8032 |
| Lot Number | 0000911374 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-04-29 |