MAUDE Adverse Event Report: UNOMEDICAL S.A. DE C.V. OXYGEN & AEROSOL THERAPY; BAG, RESERVOIR

Model Number I001423

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2014

Event Type  malfunction  

Event Description

It was reported that during the check, prior to use, a clinician found a tear on the reservoir bag.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.A final quality evaluation was performed on (b)(4) 2014.A complaint sample received on (b)(4) 2014 was examined and quality issue confirmed.A section of the reservoir bag was torn or opened during a visual inspection.The cause was a poor sealing of bag which could cause the bag to tear while it was inflating during check prior to use.The possible root cause was a failure of bag supplier.A capa (corrective action preventative action) was created to document the investigation.Batch record review indicate that the reservoir bag was properly inspected and tested, and no torn bags were detected in inspections performed during manufacturing.A one year historical review of complaints revealed this is the first complaint of this nature for this product lot; this could be considered as an isolated quality issue.Immediate action was taken and re-inspection of stocks of re-breathing bag which indicated that no torn bags were observed in addition the following actions will be taken: submit bag supplier a corrective action request in order to determine further actions by bag supplier.Increase inspection of re-breathing bag to a tightened sampling plan at incoming inspection for (b)(4) consecutive lots starting (b)(4) 2014.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: OXYGEN & AEROSOL THERAPY
• Type of Device: BAG, RESERVOIR
• Manufacturer (Section D): UNOMEDICAL S.A. DE C.V.; av. industrial falcon secc. 4; lote 7, parque ind. del norte; reynosa 8873 6; MX 88736
• Manufacturer Contact: matthew walenciak, interim assoc ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3966494
• MDR Text Key: 16633831
• Report Number: 9680866-2014-00006
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/01/2016
• Device Model Number: I001423
• Device Catalogue Number: I001423
• Device Lot Number: 99311
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1