MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-02-20 for MASK AIR ENTRAIN ADULT 50/CS 001240-A manufactured by Carefusion.
[3435530]
Manufacturing plant confirmed that upon sample return, an occluded 50% venti adaptor was discovered. No patient impact, discovered prior to use.
Patient Sequence No: 1, Text Type: D, B5
[10571976]
(b)(4): an unused sample was received at the manufacturing plant for evaluation. Upon completion of carefusion's investigation, a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[21403125]
(b)(4). Evaluation summary: upon sample return, a 50% venturi adapter was found to be occluded. The adapter is a supplied component to carefusion. The supplier that manufactures this part was notified of the defect. A project initiation was requested to the supplier by carefusion to determine the root cause for the adapter being occluded. Carefusion plans to implement additional quality inspections at the assembly line process in order to immediately detect this type of failure if it were to recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2013-00016 |
| MDR Report Key | 2969241 |
| Report Source | 07 |
| Date Received | 2013-02-20 |
| Date of Report | 2013-02-14 |
| Date of Event | 2013-02-14 |
| Date Mfgr Received | 2013-03-01 |
| Date Added to Maude | 2013-05-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO85PARQUE INDUST.MEXICALI III |
| Manufacturer City | MEXICALI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASK AIR ENTRAIN ADULT 50/CS |
| Generic Name | MASK, OXYGEN, LOW CONCENTRATION, VENTURI |
| Product Code | BYF |
| Date Received | 2013-02-20 |
| Returned To Mfg | 2013-02-14 |
| Model Number | 001240-A |
| Lot Number | 000493387 |
| Operator | SERVICE AND TESTING PERSONNEL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN RD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-20 |