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

Catalog Number 1060

Device Problem Inflation Problem (1310)

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

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received by the manufacturer at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper and thorough investigation to confirm the alleged defect reported and determine the root cause, it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available at a later date this report will be updated accordingly.

Event Description

Customer complaint alleges "when the user started using the mask on the patient, the bag did not inflate.Therefore, a new unit was used instead." there was no injury or patient consequence reported.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and no issues were found.Air was flowing properly.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found and the device functioned as intended.

Event Description

Customer complaint alleges "when the user started using the mask on the patient, the bag did not inflate.Therefore, a new unit was used instead." there was no injury or patient consequence reported.

• Brand Name: MASK,NON-REBREATH W/O SAFETY VENT,ELONGA
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7053720
• MDR Text Key: 93453531
• Report Number: 3004365956-2017-00414
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

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: No Information
• Device Catalogue Number: 1060
• Device Lot Number: 74C1702557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 11/22/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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