MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK, MEDIUM CONC, ELONG, ADULT; OXYGEN MASK

Catalog Number 1041

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2015

Event Type  malfunction  

Event Description

The customer alleges that the mask with connector (connector had a hole in it) was leaking to the point that the pt was de-saturating in the operating room setting.No pt injury.

Manufacturer Narrative

(b)(4).A visual inspection of the prod involved in the complaint was not conducted since the product or a picture of the defect was not provided.However, current production samples of catalog number 1041 mask, medium conc, elong, adult batch 74d1501382 were inspected and no issues were found than can lead to the condition reported by the customer.A dimensional and functional inspection of the prod involved in the complaint could not be conducted since the prod was not returned.A device history record review could not be conducted since the lot number was not provided.No corrective action can be established since the lot number was not provided and a sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed due to the lack of sample and not lot number provided for investigation.If the sample becomes available this investigation will be updated with the eval results.

• Brand Name: HUDSON MASK, MEDIUM CONC, ELONG, ADULT
• Type of Device: OXYGEN MASK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4752183
• MDR Text Key: 5826631
• Report Number: 3004365956-2015-00134
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1