MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-22 for MASK AIR ENTRAIN ADULT 50/CS 001240-A manufactured by Carefusion.
[3121336]
Customer stated that on (b)(6) 2013, an issue was observed with the cardinal health oxygen mask 001240 lot 000493387. There is no opening for oxygen to go through when the mask is set at 50% adapter where the line connects to the venturi adapter. Customer is in the process of pulling all of the masks to check their patency on all settings. Samples will be returned for evaluation. Customer stated that there was no lasting patient harm. Additional information was received from the customer on (b)(6) 2013: the ,50 venti mask was set up on a patient when the therapist recognized there was no flow coming out. It was recognized that there was no patency in the. 50 venti clip. The therapist recognized the issue immediately. The hospital staff pulled all the product from their shelves and stock and no longer wishes to use this product. There remains 5 cases of product in their department with two separate lot numbers. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[10492124]
(b)(4) - device is in the process of being sent to manufacturing plant. Upon completion of carefusion's investigation, a follow-up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[10524681]
(b)(4). Evaluation summary: the sample was returned for evaluation. Upon visual inspection, we confirmed the 50% venti adapter 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. In addition, 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
[21362580]
(b)(4):carefusion received facility medwatch on (b)(4) 2013. The following information was provided, "the 50% fio2 adapter piece of the oxygen kit did not allow for oxygen to flow through and the patient desaturated. No patient harm but the respiratory tech discovered that there is no hole in that piece. All other pieces are fine. Multiple failures have been found in this one lot. " upon completion of carefusion's investigation a follow up medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2013-00003 |
| MDR Report Key | 2925674 |
| Report Source | 05 |
| Date Received | 2013-01-22 |
| Date of Report | 2013-01-02 |
| Date of Event | 2013-01-02 |
| Date Mfgr Received | 2013-03-01 |
| Date Added to Maude | 2013-04-12 |
| 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 | 2013-01-22 |
| Model Number | 001240-A |
| Lot Number | 000493387 |
| Device Availability | Y |
| 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 | 2013-01-22 |