MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONG; OXYGEN MASK - NON REBREATHING

Catalog Number 1059

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Code Available (3191)

Event Date 03/05/2014

Event Type  malfunction  

Event Description

The complaint is reported as: "there's a problem with the new masks with high o2 concentration.Device is too rigid making it difficult to administer enough oxygen to the patient.Consequences: the patient was not well oxygenated as it was impossible to connect the patient." the current condition of the patient is unknown.

Manufacturer Narrative

A device history record (dhr) review could not be performed as the lot number reported was not a valid lot number.The sample was not returned for evaluation at the time of this report.A sample from current production was verified to identify any issue that could lead to the reporter defect, and no issues were found.The production sample was working properly.The reported complaint could not be confirm based on the information provided.In order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If the sample is received, a follow-up report will be submitted with the investigation results.

• Brand Name: HUDSON MASK, NON-REBREATH W/SAFETY VENT, ELONG
• Type of Device: OXYGEN MASK - NON REBREATHING
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: katharine tarpley ; po box 12600; rpt, NC 27709 ; 9194334854
• MDR Report Key: 4188202
• MDR Text Key: 5095497
• Report Number: 3004365956-2014-00378
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1059
• Device Lot Number: 13/45/6
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/17/2014
• Initial Date FDA Received: 10/16/2014
• 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: Unknown
• Patient Sequence Number: 1